CancerConsult CancerNCT06971263
Influence of Dietary and Palliative Care Consultation on the Quality of Life (Qol), Performance Status, and Nutritional Status of Cancer Patients in Bangladesh
A study testing Consultation on both nutrition, and palliative care and Counselling on nutrition and healthy diet in people with Cancer, run by Jahangirnagar University at 3 sites in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- Consultation on both nutrition, and palliative care and Counselling on nutrition and healthy diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 3 sitesBangladesh
- Study dates
- 15 Jun 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cancer Patients under standard treatment, Willing to participate, Who can eat orally, and Health indicators are measurable.
Who cannot join
- Cancer Patients under no standard treatment, Not willing to participate, Who cannot eat orally, Health indicators are not measurable, and Death.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh3 sites, 2 recruiting
- Recruiting
Chittagong Medical College Hospital (CMCH)
Chittagong, Chattogram, 4203
Dr. Banani Barua, MBBS, M.Phil., +8801712129595, bananibarua6@gmail.com
Syed Billal Hossain, MPH
- Recruiting
Mymensingh Medical College Hospital (MMCH)
Mymensingh, Mymensingh, 2200
Dr. Md. Ashraful Islam, MBBS, +8801684155883, islam.mdashraful883@gmail.com
Syed Billal Hossain, MPH
- Active, not recruiting
Department of Public Health and Informatics, Jahangirnagar University
Savar Upazila, Dhaka Division, 1342
About this study
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.
- Conditions
- Cancer
- Being tested
- Consultation on both nutrition, and palliative care, Counselling on nutrition and healthy diet
- Keywords
- Cancer, Dietary Consultation, Palliative Care, Quality of Life, Performance Status, Nutritional Status
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consultation on both nutrition, and palliative careBehavioural
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.
Counselling on nutrition and healthy dietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients with both face-to face nutrition and palliative care counselling | Active comparator | Recruited cancer patients will be given both nutrition and palliative care counselling during face-to face surveys. Receives: Behavioral: Consultation on both nutrition, and palliative care |
| Cancer patients with face-to face nutrition counselling | Active comparator | Recruited cancer patients will be given nutrition counselling on healthy diet during face-to face surveys. Receives: Behavioral: Counselling on nutrition and healthy diet |
| Cancer patients without any consultation or intervention | No intervention | Recruited cancer patients will not be given any nutrition and palliative care counselling or interventions during face-to face surveys. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: From enrollment to the end of interventions at 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start15 Jun 2025
- Primary completionApr 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial (RCT)
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jahangirnagar University
- Sponsor type
- University, hospital or other
- Collaborators
- Bangladesh University Grants Commission (UGC)
- Responsible party
- Principal investigator, Syed Billal Hossain, Jahangirnagar University
- Investigators
- Syed Billal Hossain, MPH, Principal investigator, Jahangirnagar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971263
- Sponsor's protocol ID
- BBEC-JU-M2025-02-199
- Acronym
- Consult Cancer
- Status last verified
- Aug 2025
- First submitted
- 17 Apr 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD related to the cancer patients with intervention might be shared on reasonable requests related to research, review and citation.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Dietary and Palliative Care Consultation on the Quality of Life (Qol), Performance Status, and Nutritional Status of Cancer Patients in Bangladesh
- ClinicalTrials.gov ID
- NCT06971263
- Acronym / sponsor ID
- Consult Cancer / BBEC-JU-M2025-02-199
- Conditions
- Cancer
- Keywords
- Cancer, Dietary Consultation, Palliative Care, Quality of Life, Performance Status, Nutritional Status
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- Jahangirnagar UniversityUniversity, hospital or other
- Collaborators
- Bangladesh University Grants Commission (UGC)
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized Control Trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Cancer patients with both face-to face nutrition and palliative care counselling | Active comparator | Behavioral: Consultation on both nutrition, and palliative careRecruited cancer patients will be given both nutrition and palliative care counselling during face-to face surveys. |
| Cancer patients with face-to face nutrition counselling | Active comparator | Behavioral: Counselling on nutrition and healthy dietRecruited cancer patients will be given nutrition counselling on healthy diet during face-to face surveys. |
| Cancer patients without any consultation or intervention | No intervention | –Recruited cancer patients will not be given any nutrition and palliative care counselling or interventions during face-to face surveys. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Cancer Patients under standard treatment, Willing to participate, Who can eat orally, and Health indicators are measurable.
Key exclusion criteria (1 listed)
- Cancer Patients under no standard treatment, Not willing to participate, Who cannot eat orally, Health indicators are not measurable, and Death.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Consultation on both nutrition, and palliative careThe 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. | Behavioural | Cancer patients with both face-to face nutrition and palliative care counselling |
| Counselling on nutrition and healthy dietThe 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. | Behavioural | Cancer patients with face-to face nutrition counselling |
Primary outcome
Patient-Generated Subjective Global Assessment (PG-SGA) Scale
Time frame: From enrollment to the end of interventions at 10 weeks.
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.
1 secondary outcome
Eastern Cooperative Oncology Group's (ECOG) scale
Time frame: From enrollment to the end of interventions at 10 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)Link provided by the sponsor.
- Patient-Generated Subjective Global Assessment (PG-SGA) Nutrition scaleLink provided by the sponsor.
- Eastern Cooperative Oncology Group's (ECOG) Performance Status scaleLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD related to the cancer patients with intervention might be shared on reasonable requests related to research, review and citation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Syed Billal Hossain, MPH principal investigator
Jahangirnagar University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consultation on both nutrition, and palliative care and Counselling on nutrition and healthy diet in people with Cancer, run by Jahangirnagar University at 3 sites in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Syed Billal Hossain, MPH (+8801792564446, sbh.raaj@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Generated Subjective Global Assessment (PG-SGA) Scale (time frame: From enrollment to the end of interventions at 10 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.