ClinicalTrials.gg
RecruitingNCT06588933Updated Sep 19, 2024

TQ-PAL Development and Validation

An observational study in Altered Taste, sponsored by Prof Andrew Davies. Recruiting at 1 site in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Prof Andrew Davies · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Sep 2023; still recruiting 3 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

Taste problems are common among patients with advanced cancer. These symptoms can affect the pleasure of eating and drinking, reduce dietary intake, cause low mood, and a lower quality of life. There is no validated tool to assess taste disturbances and their impact on patients with advanced cancer. This study will develop and validate a novel assessment tool to assess taste disturbances and their impact on patients with advanced cancer.

Read the detailed description

Patients with advanced cancer often develop taste disturbances. A recent literature review reported a median prevalence of 55%, with prevalence ranging from 27-93%. Studies have shown taste disturbance is usually a persistent symptom, is often 'moderate-to-severe' in intensity, and is often associated with significant distress. Taste disturbance may have a major impact on the experience and pleasure associated with eating and drinking. Taste disturbance may have a major impact on nutritional intake. It may be associated with low mood / depression, social isolation, and an impaired quality of life.

The aforementioned literature review identified, importantly, that the terminology used in the published literature varied, which may have had an effect on the results obtained, especially prevalence statistics. The review identified the need for "development/validation studies of a taste-specific assessment tool for this group of patients - there is a need for a tool that not only assesses the problem but can also assess the response to treatment for the problem, utilising patient reported outcome measures."

02

Conditions studied

  • Altered Taste

Keywords

  • neoplasm
03

In context

Dysgeusia

52 studies on the registry are indexed under Dysgeusia; 12 are open to participants now.

This study's planned enrollment of 200 is above the median of 104 across 22 observational studies indexed under Dysgeusia.

Browse Dysgeusia studies →

Lead sponsor

This is the only study on the registry with Prof Andrew Davies as lead sponsor.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients who are currently under the care of oncology or palliative care who have an incurable cancer. Patients will be identified by the clinical teams at the study sites, informed about the study, and (if interested in taking part in the study) referred to the research team. Participants will be screened for inclusion by asking 1. Over the past 2 weeks have you experienced taste problems?" If yes to the question, "How severe was it? (Options- Slight/Moderate/Severe/Very severe)". Patients must score as moderate/severe/very severe

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

18 years of age Diagnosis of locally advanced or cancer Referred to palliative care/oncology services Taste problems rated 'moderate' or worse over previous 2-week period Good understanding of English

Exclusion criteria

Exclusion Criteria:

Cognitive impairment (unable to provide consent / complete questionnaire) Taste problems precedes cancer diagnosis. Head and neck surgery Head and neck radiotherapy Salivary gland disorders (e.g., Sjogren's Syndrome) In the 'Deteriorating' or 'Terminal' Phase of illness

Terms in these criteria, in plain language(1)

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.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Interventions

  • Othercompletion of a questionnaire

    completion of a questionnaire by participant

06

What researchers measure

Primary outcomes

  1. To develop a novel assessment tool to assess taste disturbances in patients with advanced cancer

    To develop the Taste Questionnaire in Palliative Care (TQ-PAL) to assess taste disturbances and their impact on patients with palliative care. It's domains include the effect on food intake, social inclusion, and quality of life

    Time frame: December 2025

  2. To validate the newly developed Taste Questionnaire in Palliative Care (TQ-PAL)

    To test the TQ-PAL for face, content, construct, convergent and reliability validation.

    Time frame: December 2025

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Hannon M, Shaw A, Connolly M, Davies A. Taste disturbance in patients with advanced cancer: a scoping review of clinical features and complications. Support Care Cancer. 2023 Sep 6;31(10):562. doi: 10.1007/s00520-023-08012-x. PubMed 37672147 ↗
  • McGettigan N, Dhuibhir PU, Barrett M, Sui J, Balding L, Higgins S, O'Leary N, Kennedy A, Walsh D. Subjective and Objective Assessment of Taste and Smell Sensation in Advanced Cancer. Am J Hosp Palliat Care. 2019 Aug;36(8):688-696. doi: 10.1177/1049909119832836. Epub 2019 Mar 3. PubMed 30827119 ↗
  • 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 ↗
  • Kirkova J, Walsh D, Rybicki L, Davis MP, Aktas A, Tao Jin, Homsi J. Symptom severity and distress in advanced cancer. Palliat Med. 2010 Apr;24(3):330-9. doi: 10.1177/0269216309356380. Epub 2009 Dec 16. PubMed 20015920 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2023 (actual). Primary completion is estimated for Dec 2025, 27 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 5, 2024
First posted
Sep 19, 2024
StartActual
Sep 1, 2023
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2025
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06588933
Lead sponsor
Prof Andrew Davies
Responsible party
Prof Andrew Davies (Professor of Palliative Medicine, Our Lady's Hospice and Care Services) — Sponsor-investigator
First posted
Sep 19, 2024
Start date
Sep 1, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Sep 19, 2024

Study contacts

Andrew Davies, FRCP
Contact
andavies@tcd.ie
014986235
Marie Hannon, BSc
Contact
marie.hannon@ucdconnect.ie
014068720
Andrew Davies, FRCP
principal investigator · Our Lady's Hospice and Care Services

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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