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RecruitingNCT06971263Consult CancerUpdated Sep 2, 2025

Influence of Dietary and Palliative Care Consultation on the Quality of Life (Qol), Performance Status, and Nutritional Status of Cancer Patients in Bangladesh

An interventional study of Consultation on both nutrition, and palliative care and Counselling on nutrition and healthy diet in Cancer, sponsored by Jahangirnagar University. Recruiting at 3 sites in Bangladesh. Per ClinicalTrials.gov, last updated 2025-09-02.

Sponsored by Jahangirnagar University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Jun 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
215
Allocation
Randomized
Sex
All
01

Study summary

Cancer patients are more likely to have malnutrition, which has been associated with poorer quality of life, higher morbidity, mortality rates, and impaired efficacy and tolerance to therapy. Malnutrition is thought to afflict the cancer patients, with weight loss and varied degrees of asthenia being the main symptoms. In fact, malnutrition can increase the risk of surgical complications such as anastomosis dehiscence, poor wound healing, morbidity, and mortality. Quality of Life is among the most important health issues for cancer patients. Patients view it as a specific and complex type of patient-reported outcomes (PROs) that considers their social, economic, psychological, and physical activities. The quality of life for cancer patients is often lower than for the general population. Despite the fact that several studies in the Western population have suggested a relationship between nutritional status and quality of life (QoL). There aren't many reliable, in-depth studies on the effectiveness of nutritional testing and early malnutrition therapy, as well as to look at the nutritional health and quality of life of cancer patients in Bangladesh. Therefore, the aim of this study is to outline the Influence of Dietary and Palliative Care Consultation on the Quality of Life (Qol), Performance Status, and Nutritional Status of Cancer Patients in Bangladesh. To conduct this randomized control trial (RCT), data will be collected through 3 observations: baseline survey with two follow-up surveys on the following months from the selected cohorts of cancer patients who will be receiving cancer treatments. There will be two groups of cohort, one will be given nutrition and palliative care counselling will be given as intervention during each observation and another group will be without consultancy. "The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0 (EORTC-QLQ C30)", "The Patient-Generated Subjective Global Assessment PG-SGA)" to estimate nutritional status, and "The Eastern Cooperative Oncology Group's (ECOG) scale" to determine the performance status (PS) will be used as instruments to collect data.

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Conditions studied

  • Cancer

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Keywords

  • Cancer
  • Dietary Consultation
  • Palliative Care
  • Quality of Life
  • Performance Status
  • Nutritional Status
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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 215 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

This is the only study on the registry with Jahangirnagar University as lead sponsor.

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

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Cancer Patients under standard treatment, Willing to participate, Who can eat orally, and Health indicators are measurable.

Exclusion criteria

Exclusion Criteria:

  • Cancer Patients under no standard treatment, Not willing to participate, Who cannot eat orally, Health indicators are not measurable, and Death.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
215 participants (estimated)

Study arms

  • Active comparator
    Cancer patients with both face-to face nutrition and palliative care counselling

    Recruited cancer patients will be given both nutrition and palliative care counselling during face-to face surveys.

    Behavioral: Consultation on both nutrition, and palliative care

  • Active comparator
    Cancer patients with face-to face nutrition counselling

    Recruited cancer patients will be given nutrition counselling on healthy diet during face-to face surveys.

    Behavioral: Counselling on nutrition and healthy diet

  • No intervention
    Cancer patients without any consultation or intervention

    Recruited cancer patients will not be given any nutrition and palliative care counselling or interventions during face-to face surveys.

Interventions

  • BehavioralConsultation on both nutrition, and palliative care

    The intervention on the nutrition and palliative care components will include open-ended consultations based on ESPEN practical guidelines on nutrition in cancer patients with one cancer center dietitian and one palliative care physician to discuss patient needs and required to improve their health consequences.

  • BehavioralCounselling on nutrition and healthy diet

    The intervention on the nutrition and healthy diet components will include open-ended consultations based on ESPEN practical guidelines on nutrition in cancer patients with one cancer center dietitian to discuss patient dietary needs for improving their health consequences.

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What researchers measure

Primary outcomes

  1. Patient-Generated Subjective Global Assessment (PG-SGA) Scale

    The Patient-Generated Subjective Global Assessment (PG-SGA) instrument will be used to diagnose nutrition. The technique permits categorizing the nutritional evaluation into three groups: A for well-nourished, B for suspected or moderate malnutrition, and C for severe malnutrition. Weight in kilograms divided by height in squared meter is known as the body mass index (BMI). In addition to PG-SGA, BMI will be calculated and categorized according to the age-specific and sex-specific chart created by the US Centers for Disease Control and Prevention.

    Time frame: From enrollment to the end of interventions at 10 weeks.

Secondary outcomes

  1. Eastern Cooperative Oncology Group's (ECOG) scale

    The Eastern Cooperative Oncology Group's (ECOG) scale will be used to determine the performance status (PS). The ECOG divides performance scales into five categories: "Zero- fully active"; "One -limited in physically demanding activity but ambulatory and able to perform work of a light or sedentary nature"; "Two- refers to being ambulatory and capable of all self-care but unable to perform any work activities"; "Three- limited capacity for self- care"; "Four- refers to being completely inactive"; and "Five- Dead".

    Time frame: From enrollment to the end of interventions at 10 weeks.

Other outcomes

  1. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire version 3.0 (EORTC-QLQ-C30) scale

    The EORTC-QLQ-C30 will be used in all patients to assess Quality of Life. This instrument is a 30-item cancer-specific questionnaire including six function scales (physical, emotional, cognitive, social, role, and global health/QoL), three symptom scales (fatigue, pain, nausea/ vomiting), and six single items assessing symptoms and the financial impact of the disease. Higher scores on the function scales indicate better functioning whilst higher scores on the symptom scales and single items denote increased symptomatology or worse financial impairment. Original scores will be linearly transformed to obtain quantified scores within the range 0 to 100. In addition, for better validation in the clinical context, overall scores derived from function scales, symptom scales and single items, will be calculated on the basis of the very high statistical significance of inter-scale correlations according to to EORTC's guidelines.

    Time frame: From enrollment to the end of interventions at 10 weeks.

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Study locations

2 of 3 sites recruiting
  • Chittagong Medical College Hospital (CMCH)
    Chittagong, Chattogram 4203, Bangladesh
    • Dr. Banani Barua, MBBS, M.Phil. · Contact · bananibarua6@gmail.com · +8801712129595
    • Syed Billal Hossain, MPH · Principal investigator
    Recruiting
  • Department of Public Health and Informatics, Jahangirnagar University
    Savar Upazila, Dhaka Division 1342, Bangladesh
    Active, not recruiting
  • Mymensingh Medical College Hospital (MMCH)
    Mymensingh, Mymensingh 2200, Bangladesh
    Recruiting
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References and documents

Individual participant data

Plan to share: Yes — IPD related to the cancer patients with intervention might be shared on reasonable requests related to research, review and citation.

Supporting information: Study protocol, Icf

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06971263
Lead sponsor
Jahangirnagar University
Collaborators
Bangladesh University Grants Commission (UGC)
Responsible party
Syed Billal Hossain (PhD Student, Jahangirnagar University) — Principal investigator
First posted
May 14, 2025
Start date
Jun 15, 2025
Primary completion
Apr 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Sep 2, 2025

Study contacts

Syed Billal Hossain, MPH
Contact
sbh.raaj@gmail.com
+8801792564446
Mahfuza Mubarak, PhD
Contact
mahfuza@juniv.edu
+8801311334033
Syed Billal Hossain, MPH
principal investigator · Jahangirnagar University

Oversight

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

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