ClinicalTrials.gg
CompletedNCT01540045Updated Feb 28, 2024Results posted

Effect of Chemotherapy With Paclitaxel/Cisplatin on Development Dysgeusia in Non Small Cell Lung Cancer

An observational study in Non-Small Cell Lung Cancer, Dysgeusia and Taste Disorders, sponsored by Instituto Nacional de Cancerologia de Mexico. Completed at 1 site in Mexico. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Instituto Nacional de Cancerologia de Mexico · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 90 Years
Sex
All
01

Study summary

One of the most widely used treatments for non-small cell lung cancer (NSCLC) is the combination of paclitaxel-cisplatin. These drugs may contribute to taste alterations like dysgeusia. Which alters the feeding of cancer patients, contributing to the anorexia, weight loss and malnutrition, which leads to a prognostic impact in a lower patient response to chemotherapy, radiotherapy and surgical treatment as well as increased toxic effects, impacting treatment discontinuation and therefore, morbidity and survival of patients. The objective of this study is to describe the threshold of perception and recognition of basic tastes in patients with NSCLC before treatment with platin and paclitaxel-based chemotherapy and after the second cycle, and analyze the effect in the developement of dysgeusia, as well as the association between these and the nutritional status and quality of life.

Read the detailed description

Lung cancer is the leading cause of death from malignancies in our country. It was recently reported to induce 11.5% of cancer deaths in Mexico, with a rate of 6.5 per 100 000 people.

Non-Small Cell Lung Cancer (NSCLC) accounts for 80% of all lung cancer cases. Less than 20% has resectable disease and in the National Cancer Institute of Mexico exclusively less than 2%, representing chemotherapy the standard of care in these patients.

One of the most widely used drug combinations is paclitaxel-cisplatin. It has been reported a prevalence of malnutrition in 60 to 79% in this type of cancer, being the major contributor to morbidity and mortality. The etiology resides both in the systemic effects of the tumor and toxic effects of treatment as low levels hematologic, nausea, vomiting, mucositis, anorexia, dysgeusia, among others.

Weight loss has a strong impact on the response to chemotherapy, radiotherapy and surgery, as well as increased toxic effects impacting the discontinuation of treatment and is considered an independent predictor of survival for most patients with NSCLC. Is estimated that over 20% of cancer patients the cause of death are inanition effects.

Among the most frequent symptoms in advanced unresectable cancer or its treatment that may affect food intake and hence nutritional status, are the early satiety and dysgeusia (61% and 46% respectively). As are difficult to change early satiety, dysgeusia is a field for selecting strategies in its management.

The dysgeusia is defined as a change in taste that can manifest as a distortion of taste, lack of taste (ageusia), decreased sensitivity of perception (hypogeusia) or increased sensitivity to some or all flavors (hypergeusia).

The development of dysgeusia have clinical significance in the etiology of cancer anorexia because it can affect eating habits and contribute to weight loss or malnutrition and consequently affect the quality of life.

The chemotherapy may contribute to dysgeusia. It has reported a prevalence of 56.3% of Dysgeusia in cancer patients under this type of treatment. As well, zinc deficiency has been associated with the hypogeusia, this metal to be involved at various levels in the physiology of the role of taste at various levels of cell several organization.

Several studies have linked consumption dysgeusia with energy and macronutrients, weight loss, lack of appetite and early satiety.

The type of tumor, stage, chemotherapy regimen and serum zinc levels are associated with dysgeusia, but the exact mechanism underlining these disturbances are not known at totality. No known if chemotherapy or before this is presented dysgeusia. In addition there are few studies in this area and with methodological weaknesses, among which include heterogeneous population (patients with a diagnosis of malignancy of breast, lung, prostate, multiple myeloma and lymphoma), different patterns of treatment(different chemotherapy drugs, radiotherapy schedules and combination of both forms of measurement of dysgeusia, besides the absence of dysgeusia baseline evaluation before chemotherapy to establish a causal association between chemotherapy and taste alteration.

Also, is unknown if dysgeusia impact on body composition determined by bioelectrical impedance, phase angle in and consumption of micronutrients (iron, sodium, zinc, B6, B12).

That's why is necessary to continue studying this phenomenon to develop a better understanding of the nature, frequency, severity and duration of dysgeusia in patients with advanced lung cancer, the role that zinc exerts in its development and its impact on consumption food, anthropometric parameters and quality of life in such patients before and after chemotherapy in the same regimen of chemotherapy.

02

Conditions studied

  • Non-Small Cell Lung Cancer
  • Dysgeusia
  • Taste Disorders
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Keywords

  • Non-Small Cell Lung Cancer
  • Dysgeusia
  • Antineoplastic Combined Chemotherapy Protocols
  • Paclitaxel
  • Cisplatin
03

In context

Carcinoma, Non-Small-Cell Lung

7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.

This study's enrollment of 40 is below the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Instituto Nacional de Cancerologia de Mexico is the lead sponsor of 41 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Outpatients from National Cancer Institute with stage III and IV NSCLC candidates for 1 st line chemotherapy paclitaxel-cisplatin based agreeing to participate in the study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients over 18 years old with INCan histopathological diagnosis of Lung Cancer Stage III or IV
  • score ≤ 2
  • Candidates for chemotherapy based 1 st Paclitaxel / cisplatin 200 mg/m2 and 75 every 3 weeks
  • Signed (and ethical scientific committee No. (010/023 (IMO) (CB/618

Exclusion criteria

Exclusion Criteria:

  • Patients who withdraw their consent and not want to continue with the evaluation of the study
  • Common cold or hay fever, recent dental procedure, evidence of gingival inflammation or infection or oral mucosa
  • People diagnosed with epilepsy or some other neurological disorders associated
  • Concomitant radiotherapy in head and neck.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)

Groups and cohorts

  • BASELINE

    Outpatients from National Cancer Institute with stage III and IV NSCLC candidates for 1 st line chemotherapy paclitaxel-cisplatin based agreeing to participate in the study

06

What researchers measure

Primary outcomes

  1. Dysgeusia (UMAMI Perception)

    Describe the threshold of perception and recognition (PT and RT, respectively) umami) with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.

    Time frame: Change from Baseline in threshold of perception at 6 weeks

  2. Dysgeusia (UMAMI Recognition)

    Describe the threshold recognition (RT) of umami with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.

    Time frame: Change from Baseline in threshold of perception at 6 weeks

  3. Dysgeusia (SWEET Perception)

    Describe the threshold perception (PT) of sweet taste with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.

    Time frame: Change from Baseline in threshold of perception at 6 weeks

  4. Dysgeusia (SWEET Recognition)

    Describe the recognition threshold (RT) of sweet taste with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.

    Time frame: Change from Baseline in threshold of perception at 6 weeks

  5. Dysgeusia (BITTER Perception)

    Describe the perception threshold (PT) of bitter taste with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.

    Time frame: Change from Baseline in threshold of perception at 6 weeks

  6. Dysgeusia (BITTER Recognition)

    Describe the recognition threshold (RT) of bitter taste with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.

    Time frame: Change from Baseline in threshold of perception at 6 weeks

  7. Dysgeusia (UMAMI Dilutions Dichotomized)

    We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami taste. (perception)

    Time frame: pre - post chemotherapy (6 weeks)

  8. Dysgeusia (SWEET Dilutions Dichotomized)

    We divide dilutions in two groups and dichotomized the patients into high and low sensibility to sweet taste.

    Time frame: pre - post chemotherapy (6 weeks)

  9. Dysgeusia (BITTER Dilutions Dichotomized)

    We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami, bitter and sweet tastes

    Time frame: pre - post chemotherapy (6 weeks)

Secondary outcomes

  1. BODY COMPOSITION

    fat mass and lean body mass pre-post chemotherapy

    Time frame: Change from Baseline in perception and recognition thresholds at 6 weeks

  2. Body Mass Index

    Body mass index, using the formula kg/m\^2

    Time frame: Change from Baseline in threshold of perception and recognition at 6 weeks

  3. Subjective Global Assessment

    validated questionnaire to identify patients with malnutrition or risk of malnutrition Subjective global assessment (PG-SGA) was used to assess and classify patients as having severe or moderate malnourishment (B or C) or as being well nourished (A).

    Time frame: descriptive values before chemotherapy

  4. PROTEIN AND FAT Consumption

    energy and nutrimental consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs \< Sweet perception thresholds after chemotherapy

    Time frame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks

  5. IRON Consumption

    IRON consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs \< Sweet perception thresholds after chemotherapy

    Time frame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks

  6. Quality o f Life

    The HRQL evaluation was assessed using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer and for LC (EORTC-QLQ-C30 and QLQ-LC13). \[18, 19\] Scores for the multi-item functional or symptom scales and the single items scales were calculated using a linear transformation of raw scores to produce a range from 0 to 100, as described by EORTC. A score of 100 represents the best score for the global health status and functional scales of QoL or 0 in the symptom rating.

    Time frame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks

  7. Change From Baseline in Albumin After 2 Cycles of Chemotherapy

    comparison of patients who increased or decreased their sensibility to the PT of umami taste

    Time frame: participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks

  8. Peripheral Neuropathy (QLQ-C30 Version 3, EORTC)

    comparison of peripheral neuropathy patients who increased or decreased their sensibility to the PT of umami taste The HRQL evaluation was assessed using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer and for LC (EORTC-QLQ-C30 and QLQ-LC13). Scores for the multi-item functional or symptom scales and the single items scales were calculated using a linear transformation of raw scores to produce a range from 0 to 100, as described by EORTC. A score of 100 represents the best score for the global health status and functional scales of QoL or 0 in the symptom rating.

    Time frame: participants were followed for the duration of 2 cycles of chemotherapy, an average of 6 weeks

  9. Global Status of Quality of Life (C-30,LC13 EORTC)

    differences in global status of QoL scale (C-30,LC13 EORTC) between those with more or less sensibility to recognize the umami taste. score of scale 0-100, a higher score represents better overall state.

    Time frame: time between baseline and before 2 cycles of chemotherapy, an average of 6 weeks

07

Results

Posted Mar 18, 2015
Limitations and caveats
No analysis of serum zinc was performed and a small number of subjects analyzed.

Participant flow

We recruit patients since September 2010 to July 2012

Participant flow — Overall Study
MilestonePre-chemotherapy Patientes =40
Started40
Completed40
Not completed0

Outcome measures

PrimaryDysgeusia (UMAMI Perception)

Describe the threshold of perception and recognition (PT and RT, respectively) umami) with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.

Time frame:
Change from Baseline in threshold of perception at 6 weeks
Reported as:
Median · μmol/ml
Dysgeusia (UMAMI Perception)
μmol/mlPre-chemotherapy PatientesPost-chemotherapy Patients
Dysgeusia (UMAMI Perception).3 (.3 to 3.3).3 (.3 to 2.7)
Statistical analysis
  • Pre-chemotherapy Patientes vs Post-chemotherapy Patients · Wilcoxon (Mann-Whitney) · p = 0.013
SecondaryBODY COMPOSITION

fat mass and lean body mass pre-post chemotherapy

Time frame:
Change from Baseline in perception and recognition thresholds at 6 weeks
Reported as:
Mean · kg
BODY COMPOSITION
kgPre-chemotherapy PatientesPost-chemotherapy Patients
FAT MASS (kg)20.09 ± 7.719.67 ± 6.5
LEAN BODY MASS (kg)41.79 ± 1341.26 ± 11.9
Statistical analysis
  • Pre-chemotherapy Patientes vs Post-chemotherapy Patients · t-test, 2 sided · p = 0.671
  • Pre-chemotherapy Patientes vs Post-chemotherapy Patients · t-test, 2 sided · p = 0.694
SecondaryBody Mass Index

Body mass index, using the formula kg/m\^2

Time frame:
Change from Baseline in threshold of perception and recognition at 6 weeks
Reported as:
Mean · kg/m^2
Body Mass Index
kg/m^2Pre-chemotherapy PatientesPost-chemotherapy Patients
Body Mass Index24.5 ± 424.1 ± 4
Statistical analysis
  • Pre-chemotherapy Patientes vs Post-chemotherapy Patients · t-test, 2 sided · p = 0.118
SecondarySubjective Global Assessment

validated questionnaire to identify patients with malnutrition or risk of malnutrition Subjective global assessment (PG-SGA) was used to assess and classify patients as having severe or moderate malnourishment (B or C) or as being well nourished (A).

Time frame:
descriptive values before chemotherapy
Reported as:
Number · participants
Subjective Global Assessment
participantsPre-chemotherapy PatientesPost-chemotherapy Patientes
SGA A2623
SGA B & C1417
Statistical analysis
  • Pre-chemotherapy Patientes vs Post-chemotherapy Patientes · McNemar · p = 0.607
SecondaryPROTEIN AND FAT Consumption

energy and nutrimental consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs \< Sweet perception thresholds after chemotherapy

Time frame:
participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks
Reported as:
Mean · gr
PROTEIN AND FAT Consumption
gr≥ Sweet Perception Thresholds After Chemotherapy< Sweet Perception Thresholds After Chemotherapy
proteins59.12 ± 32.791.07 ± 33.1
animal proteins28.2 ± 1449.29 ± 18.5
fat60.1 ± 26.291.77 ± 31.6
Statistical analysis
  • ≥ Sweet Perception Thresholds After Chemotherapy vs < Sweet Perception Thresholds After Chemotherapy · t-test, 2 sided · p = 0.015
  • ≥ Sweet Perception Thresholds After Chemotherapy vs < Sweet Perception Thresholds After Chemotherapy · t-test, 2 sided · p = 0.010
  • ≥ Sweet Perception Thresholds After Chemotherapy vs < Sweet Perception Thresholds After Chemotherapy · t-test, 2 sided · p = 0.004
SecondaryIRON Consumption

IRON consumption was estimated by questionnaire SNUT difference between ≥ Sweet perception thresholds vs \< Sweet perception thresholds after chemotherapy

Time frame:
participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks
Reported as:
Mean · mg
IRON Consumption
mg≥ Sweet Perception Thresholds After Chemotherapy< Sweet Perception Thresholds After Chemotherapy
IRON Consumption10.8 ± 7.516.11 ± 6.3
PrimaryDysgeusia (UMAMI Recognition)

Describe the threshold recognition (RT) of umami with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.

Time frame:
Change from Baseline in threshold of perception at 6 weeks
Reported as:
Median · μmol/ml
Dysgeusia (UMAMI Recognition)
μmol/mlPre-chemotherapy PatientesPost-chemotherapy Patients
Dysgeusia (UMAMI Recognition)2.4 (.3 to 3.3)1.5 (.3 to 3.3)
Statistical analysis
  • Pre-chemotherapy Patientes vs Post-chemotherapy Patients · Wilcoxon (Mann-Whitney) · p = 0.28
SecondaryQuality o f Life

The HRQL evaluation was assessed using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer and for LC (EORTC-QLQ-C30 and QLQ-LC13). \[18, 19\] Scores for the multi-item functional or symptom scales and the single items scales were calculated using a linear transformation of raw scores to produce a range from 0 to 100, as described by EORTC. A score of 100 represents the best score for the global health status and functional scales of QoL or 0 in the symptom rating.

Time frame:
participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks
Reported as:
Median · Scores on a scale
Quality o f Life
Scores on a scaleHRQL Pre-chemotherapyHRQL Post-chemotherapy
Global status58.33 (0 to 100)66.67 (0 to 100)
Role functioning66.67 (0 to 100)83.33 (0 to 100)
Emotional functioning66.67 (0 to 100)91.67 (0 to 100)
Fatigue38.8 (0 to 100)22.22 (0 to 100)
Appetite loss33.33 (0 to 100)0 (0 to 100)
Constipation33.33 (0 to 100)0 (0 to 100)
Statistical analysis
  • HRQL Pre-chemotherapy vs HRQL Post-chemotherapy · Wilcoxon (Mann-Whitney) · p = 0.889
  • HRQL Pre-chemotherapy vs HRQL Post-chemotherapy · Wilcoxon (Mann-Whitney) · p = 0.293 (clinically significant)
  • HRQL Pre-chemotherapy vs HRQL Post-chemotherapy · Wilcoxon (Mann-Whitney) · p = 0.009
  • HRQL Pre-chemotherapy vs HRQL Post-chemotherapy · Wilcoxon (Mann-Whitney) · p = 0.213 (clinically significant)
  • HRQL Pre-chemotherapy vs HRQL Post-chemotherapy · Wilcoxon (Mann-Whitney) · p = 0.595 (clinically significant)
  • HRQL Pre-chemotherapy vs HRQL Post-chemotherapy · Wilcoxon (Mann-Whitney) · p = 0.068 (clinically significant)
SecondaryChange From Baseline in Albumin After 2 Cycles of Chemotherapy

comparison of patients who increased or decreased their sensibility to the PT of umami taste

Time frame:
participants were evaluated baseline and after 2 cycles of chemotherapy, an average of 6 weeks
Reported as:
Mean · g/dL
Change From Baseline in Albumin After 2 Cycles of Chemotherapy
g/dL> or = Umami Perception Thresholds< Umami Perception Thresholds
Change From Baseline in Albumin After 2 Cycles of Chemotherapy-0.4 ± 0.110.28 ± 0.1
Statistical analysis
  • > or = Umami Perception Thresholds vs < Umami Perception Thresholds · t-test, 2 sided · p = 0.05
SecondaryPeripheral Neuropathy (QLQ-C30 Version 3, EORTC)

comparison of peripheral neuropathy patients who increased or decreased their sensibility to the PT of umami taste The HRQL evaluation was assessed using the validated Mexican-Spanish version of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaires specific for cancer and for LC (EORTC-QLQ-C30 and QLQ-LC13). Scores for the multi-item functional or symptom scales and the single items scales were calculated using a linear transformation of raw scores to produce a range from 0 to 100, as described by EORTC. A score of 100 represents the best score for the global health status and functional scales of QoL or 0 in the symptom rating.

Time frame:
participants were followed for the duration of 2 cycles of chemotherapy, an average of 6 weeks
Reported as:
Median · Units on a scale
Peripheral Neuropathy (QLQ-C30 Version 3, EORTC)
Units on a scale> or = Umami Perception Thresholds< Umami Perception Thresholds
Peripheral Neuropathy (QLQ-C30 Version 3, EORTC)33.33 (0 to 100)16.66 (0 to 66.67)
Statistical analysis
  • > or = Umami Perception Thresholds vs < Umami Perception Thresholds · Wilcoxon (Mann-Whitney) · p = 0.240 (clinically significant)
SecondaryGlobal Status of Quality of Life (C-30,LC13 EORTC)

differences in global status of QoL scale (C-30,LC13 EORTC) between those with more or less sensibility to recognize the umami taste. score of scale 0-100, a higher score represents better overall state.

Time frame:
time between baseline and before 2 cycles of chemotherapy, an average of 6 weeks
Reported as:
Median · units on a scale
Global Status of Quality of Life (C-30,LC13 EORTC)
units on a scale< or = Umami Recognition Thresholds> Umami Recognition Thresholds
Global Status of Quality of Life (C-30,LC13 EORTC)75 (1.66 to 99.58)66.67 (8.33 to 100)
Statistical analysis
  • < or = Umami Recognition Thresholds vs > Umami Recognition Thresholds · Wilcoxon (Mann-Whitney) · p = 0.036
PrimaryDysgeusia (SWEET Perception)

Describe the threshold perception (PT) of sweet taste with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.

Time frame:
Change from Baseline in threshold of perception at 6 weeks
Reported as:
Median · μmol/ml
Dysgeusia (SWEET Perception)
μmol/mlPre-chemotherapy PatientesPost-chemotherapy Patients
Dysgeusia (SWEET Perception)3.5 (3.5 to 18.5)3.5 (3.5 to 18.5)
Statistical analysis
  • Pre-chemotherapy Patientes vs Post-chemotherapy Patients · Wilcoxon (Mann-Whitney) · p = 0.312
PrimaryDysgeusia (SWEET Recognition)

Describe the recognition threshold (RT) of sweet taste with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.

Time frame:
Change from Baseline in threshold of perception at 6 weeks
Reported as:
Median · μmol/ml
Dysgeusia (SWEET Recognition)
μmol/mlPre-chemotherapy PatientesPost-chemotherapy Patients
Dysgeusia (SWEET Recognition)15.5 (3.5 to 18.5)12.5 (3.5 to 18.5)
Statistical analysis
  • Pre-chemotherapy Patientes vs Post-chemotherapy Patients · Wilcoxon (Mann-Whitney) · p = 0.608
PrimaryDysgeusia (BITTER Perception)

Describe the perception threshold (PT) of bitter taste with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.

Time frame:
Change from Baseline in threshold of perception at 6 weeks
Reported as:
Mean · μmol/ml
Dysgeusia (BITTER Perception)
μmol/mlPre-chemotherapy PatientesPost-chemotherapy Patients
Dysgeusia (BITTER Perception)97 (91 to 121)91 (91 to 121)
Statistical analysis
  • Pre-chemotherapy Patientes vs Post-chemotherapy Patients · Wilcoxon (Mann-Whitney) · p = 0.035
PrimaryDysgeusia (BITTER Recognition)

Describe the recognition threshold (RT) of bitter taste with 5 dilutions with different concentrations. The patients were instructed to taste each 5 ml dilution in ascending order and to rinse the dilution around the entire oral cavity. After each rinse, the patients were asked whether the sample they took tasted different from water to identify their PT, which was assigned to the lowest concentration at which the subject perceived a difference in taste from water. If so, then the patients were asked to identify the taste to define their RT, which was assigned to the lowest concentration at which the subject identified the taste.

Time frame:
Change from Baseline in threshold of perception at 6 weeks
Reported as:
Median · μmol/ml
Dysgeusia (BITTER Recognition)
μmol/mlPre-chemotherapy PatientesPost-chemotherapy Patients
Dysgeusia (BITTER Recognition)115 (91 to 121)109 (91 to 121)
Statistical analysis
  • Pre-chemotherapy Patientes vs Post-chemotherapy Patients · Wilcoxon (Mann-Whitney) · p = 0.402
PrimaryDysgeusia (UMAMI Dilutions Dichotomized)

We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami taste. (perception)

Time frame:
pre - post chemotherapy (6 weeks)
Reported as:
Number · participants
Dysgeusia (UMAMI Dilutions Dichotomized)
participantsPre-chemotherapy PatientesPost-chemotherapy Patients
UMAMI 0.3 - 1.5 μmol/ml3136
UMAMI > 1.5 μmol/ml93
Statistical analysis
  • Pre-chemotherapy Patientes vs Post-chemotherapy Patients · McNemar · p = 0.109
PrimaryDysgeusia (SWEET Dilutions Dichotomized)

We divide dilutions in two groups and dichotomized the patients into high and low sensibility to sweet taste.

Time frame:
pre - post chemotherapy (6 weeks)
Reported as:
Number · participants
Dysgeusia (SWEET Dilutions Dichotomized)
participantsPre-chemotherapy PatientesPost-chemotherapy Patients
SWEET 3.5 - 9.5 μmol/ml2633
SWEET > 9.5 μmol/ml146
Statistical analysis
  • Pre-chemotherapy Patientes vs Post-chemotherapy Patients · McNemar · p = 0.092
PrimaryDysgeusia (BITTER Dilutions Dichotomized)

We divide dilutions in two groups and dichotomized the patients into high and low sensibility to umami, bitter and sweet tastes

Time frame:
pre - post chemotherapy (6 weeks)
Reported as:
Number · participants
Dysgeusia (BITTER Dilutions Dichotomized)
participantsPre-chemotherapy PatientesPost-chemotherapy Patients
BITTER 91 - 103 μmol/ml2635
BITTER > 109 μmol/ml144
Statistical analysis
  • Pre-chemotherapy Patientes vs Post-chemotherapy Patients · McNemar · p = 0.022

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LUNG CANCER PATIENTS———

Baseline characteristics

We invited to participate 72 patients with NSCLC newly diagnosed, but only 40 patients completed their baseline evaluation and their follow up after two cycles of chemotherapy using paclitaxel (175 mg/m2) and cisplatin (75 mg/m2). The main reason of exclusion was death followed by not returning to the institution.

Age, Continuous
Age, Continuous(years)Pre-chemotherapy Patientes =40
Mean55.5 ± 15
Sex: Female, Male
Sex: Female, Male(Participants)Pre-chemotherapy Patientes =40
Female20
Male20
Region of Enrollment
Region of Enrollment(participants)Pre-chemotherapy Patientes =40
Mexico40
08

Study locations

1 site
  • National Cancer Institute of Mexico
    Mexico city, Distrito Federal 14080, Mexico
09

References and documents

Publications

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  • Rolls ET. The representation of umami taste in the taste cortex. J Nutr. 2000 Apr;130(4S Suppl):960S-5S. doi: 10.1093/jn/130.4.960S. PubMed 10736361 ↗
  • Comeau TB, Epstein JB, Migas C. Taste and smell dysfunction in patients receiving chemotherapy: a review of current knowledge. Support Care Cancer. 2001 Nov;9(8):575-80. doi: 10.1007/s005200100279. PubMed 11762967 ↗
  • Arrieta O, Hernandez-Pedro N, Fernandez-Gonzalez-Aragon MC, Saavedra-Perez D, Campos-Parra AD, Rios-Trejo MA, Ceron-Lizarraga T, Martinez-Barrera L, Pineda B, Ordonez G, Ortiz-Plata A, Granados-Soto V, Sotelo J. Retinoic acid reduces chemotherapy-induced neuropathy in an animal model and patients with lung cancer. Neurology. 2011 Sep 6;77(10):987-95. doi: 10.1212/WNL.0b013e31822e045c. Epub 2011 Aug 24. PubMed 21865574 ↗
  • Bernhardson BM, Tishelman C, Rutqvist LE. Self-reported taste and smell changes during cancer chemotherapy. Support Care Cancer. 2008 Mar;16(3):275-83. doi: 10.1007/s00520-007-0319-7. Epub 2007 Aug 21. PubMed 17710445 ↗
  • Gupta D, Lammersfeld CA, Vashi PG, King J, Dahlk SL, Grutsch JF, Lis CG. Bioelectrical impedance phase angle in clinical practice: implications for prognosis in stage IIIB and IV non-small cell lung cancer. BMC Cancer. 2009 Jan 28;9:37. doi: 10.1186/1471-2407-9-37. PubMed 19175932 ↗
  • Hernandez-Avila M, Romieu I, Parra S, Hernandez-Avila J, Madrigal H, Willett W. Validity and reproducibility of a food frequency questionnaire to assess dietary intake of women living in Mexico City. Salud Publica Mex. 1998 Mar-Apr;40(2):133-40. doi: 10.1590/s0036-36341998000200005. PubMed 9617194 ↗
  • Thoresen L, Fjeldstad I, Krogstad K, Kaasa S, Falkmer UG. Nutritional status of patients with advanced cancer: the value of using the subjective global assessment of nutritional status as a screening tool. Palliat Med. 2002 Jan;16(1):33-42. doi: 10.1191/0269216302pm486oa. PubMed 11963449 ↗
  • Bauer J, Capra S, Ferguson M. Use of the scored Patient-Generated Subjective Global Assessment (PG-SGA) as a nutrition assessment tool in patients with cancer. Eur J Clin Nutr. 2002 Aug;56(8):779-85. doi: 10.1038/sj.ejcn.1601412. PubMed 12122555 ↗
  • Muscaritoli M, Anker SD, Argiles J, Aversa Z, Bauer JM, Biolo G, Boirie Y, Bosaeus I, Cederholm T, Costelli P, Fearon KC, Laviano A, Maggio M, Rossi Fanelli F, Schneider SM, Schols A, Sieber CC. Consensus definition of sarcopenia, cachexia and pre-cachexia: joint document elaborated by Special Interest Groups (SIG) "cachexia-anorexia in chronic wasting diseases" and "nutrition in geriatrics". Clin Nutr. 2010 Apr;29(2):154-9. doi: 10.1016/j.clnu.2009.12.004. Epub 2010 Jan 8. PubMed 20060626 ↗
  • Halyard MY, Jatoi A, Sloan JA, Bearden JD 3rd, Vora SA, Atherton PJ, Perez EA, Soori G, Zalduendo AC, Zhu A, Stella PJ, Loprinzi CL. Does zinc sulfate prevent therapy-induced taste alterations in head and neck cancer patients? Results of phase III double-blind, placebo-controlled trial from the North Central Cancer Treatment Group (N01C4). Int J Radiat Oncol Biol Phys. 2007 Apr 1;67(5):1318-22. doi: 10.1016/j.ijrobp.2006.10.046. PubMed 17394940 ↗
  • Brennan MT, Elting LS, Spijkervet FK. Systematic reviews of oral complications from cancer therapies, Oral Care Study Group, MASCC/ISOO: methodology and quality of the literature. Support Care Cancer. 2010 Aug;18(8):979-84. doi: 10.1007/s00520-010-0856-3. Epub 2010 Mar 20. PubMed 20306090 ↗
  • Gallagher P, Tweedle DE. Taste threshold and acceptability of commercial diets in cancer patients. JPEN J Parenter Enteral Nutr. 1983 Jul-Aug;7(4):361-3. doi: 10.1177/0148607183007004361. PubMed 6413712 ↗
  • Mattes RD, Cowart BJ, Schiavo MA, Arnold C, Garrison B, Kare MR, Lowry LD. Dietary evaluation of patients with smell and/or taste disorders. Am J Clin Nutr. 1990 Feb;51(2):233-40. doi: 10.1093/ajcn/51.2.233. PubMed 2305710 ↗
  • Hutton JL, Baracos VE, Wismer WV. Chemosensory dysfunction is a primary factor in the evolution of declining nutritional status and quality of life in patients with advanced cancer. J Pain Symptom Manage. 2007 Feb;33(2):156-65. doi: 10.1016/j.jpainsymman.2006.07.017. PubMed 17280921 ↗
  • Rehwaldt M, Wickham R, Purl S, Tariman J, Blendowski C, Shott S, Lappe M. Self-care strategies to cope with taste changes after chemotherapy. Oncol Nurs Forum. 2009 Mar;36(2):E47-56. doi: 10.1188/09.onf.e47-e56. PubMed 19273394 ↗
  • Steinbach S, Hummel T, Bohner C, Berktold S, Hundt W, Kriner M, Heinrich P, Sommer H, Hanusch C, Prechtl A, Schmidt B, Bauerfeind I, Seck K, Jacobs VR, Schmalfeldt B, Harbeck N. Qualitative and quantitative assessment of taste and smell changes in patients undergoing chemotherapy for breast cancer or gynecologic malignancies. J Clin Oncol. 2009 Apr 10;27(11):1899-905. doi: 10.1200/JCO.2008.19.2690. Epub 2009 Mar 16. PubMed 19289621 ↗
  • Zabernigg A, Gamper EM, Giesinger JM, Rumpold G, Kemmler G, Gattringer K, Sperner-Unterweger B, Holzner B. Taste alterations in cancer patients receiving chemotherapy: a neglected side effect? Oncologist. 2010;15(8):913-20. doi: 10.1634/theoncologist.2009-0333. Epub 2010 Jul 28. PubMed 20667968 ↗
  • Sanchez-Lara K, Sosa-Sanchez R, Green-Renner D, Rodriguez C, Laviano A, Motola-Kuba D, Arrieta O. Influence of taste disorders on dietary behaviors in cancer patients under chemotherapy. Nutr J. 2010 Mar 24;9:15. doi: 10.1186/1475-2891-9-15. PubMed 20334666 ↗
  • Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516. PubMed 21351269 ↗
  • Turcott JG, Juarez-Hernandez E, De la Torre-Vallejo M, Sanchez-Lara K, Luvian-Morales J, Arrieta O. Value: Changes in the Detection and Recognition Thresholds of Three Basic Tastes in Lung Cancer Patients Receiving Cisplatin and Paclitaxel and Its Association with Nutritional and Quality of Life Parameters. Nutr Cancer. 2016;68(2):241-9. doi: 10.1080/01635581.2016.1144075. Epub 2016 Mar 4. PubMed 26943275 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01540045
Lead sponsor
Instituto Nacional de Cancerologia de Mexico
Responsible party
Oscar Gerardo Arrieta Rodríguez (Head Of the Thoracic Oncology Clinic. SNI II, Instituto Nacional de Cancerologia de Mexico) — Principal investigator
First posted
Feb 28, 2012
Start date
Dec 2010
Primary completion
Dec 2011
Completion
May 2012
Results posted
Mar 18, 2015
Last update
Feb 28, 2024

Study contacts

Oscar G Arrieta, MD M Sc
principal investigator · Mexico. Nacional Cancer Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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