The Effect of Locally Made Nutritional Supplementation on Cancer Cachexia in Bangladesh: A Quasi-experimental Study.

NCT07613125 | Active Not Recruiting DMC

• 2 other identifiers: PR-25047GR-02602
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

Background (brief): Burden: Cancer is the sixth leading cause of death in Bangladesh, posing a significant public health challenge. Among the major complications associated with cancer, cachexia remains a critical concern. Cancer cachexia is a multifactorial syndrome characterized by severe and progressive weight loss, muscle wasting, and metabolic dysfunction, significantly impacting patient's overall health. It not only leads to a decline in quality of life but also contributes to poor treatment outcomes and reduced overall survival. Despite its profound clinical implications, effective therapeutic strategies for managing cancer cachexia remain limited. Addressing this condition is essential for improving the prognosis and well-being of cancer patients, highlighting the urgent need for further research and targeted interventions. Knowledge gap: It has been reported that a single nutritional supplement alone is not enough to combat cancer related cachexia. Many commercial formulas are available in the market, but these are costly and out of reach for the people of low- and middle-income countries. Hypothesis (if any): Egg-enriched rice starch water fortified with multivitamins and multimineral is efficient in managing cancer cachexia. Objectives: Our primary objective is to observe the effects of locally developed nutritional supplement on cancer cachexia. Methods: This will be a prospective study with quasi-experimental design to be conducted among the patients with cancer cachexia admitted to a tertiary hospital. Patients will be recruited from the department of surgical oncology, National Institute of Cancer Research \& Hospital (NICRH). Patients in intervention group will receive cooked rice starch water mixed with egg and multivitamin multimineral pre-mix for 14 days, in addition to conventional treatments for cancer. The control group will receive the conventional diet provided from hospital. Outcome measures/variables: Primary: Improvement in serum albumin and haemoglobin after nutritional supplementation Secondary: Change in quality of life, change is basal metabolic index (BMI)

Conditions

Cancer Cachexia (CC)

Outcome Measures

Primary Outcomes (1)

• Improvement in serum albumin and hemoglobin after nutritional supplementation

  Serum albumin and haemoglobin are recognized biomarker for cancer cachexia, with lower levels often correlating with the severity of the condition. To assess the biomarker study endpoints, serum samples will be collected from the participants at the beginning and endpoint of the study in both control and intervention group. These serum samples will be tested for serum albumin and serum haemoglobin level. The maximum amount of blood collected from each participant will not exceed approximately 6ml at a given time.

  At baseline and after 14th day of intervention(case) or conventional diet (control).

Secondary Outcomes (3)

• Change in quality of life

  At baseline and after 14th day of intervention(case) or conventional diet (control).

• Change is body mass index(BMI)

  At baseline and after 14th day of intervention(case) or conventional diet (control).

• Mean change in daily energy intake (kilocalories/day) and protein intake (gm/kg/day) from baseline to the end line

  At baseline and after 14th day of intervention(case) or conventional diet (control).

Study Arms (2)

Case

EXPERIMENTAL

This will be a quasi-experimental study. The participant of the case arm will receive the intervention diet along with hospital diet. All the dietary intake will be recorded in patient's daily follow-up form. Daily calory and protein intake will be calculated.

Dietary Supplement: Cooked rice starch water along with multivitamin multimineral

Control

ACTIVE COMPARATOR

This will be a quasi-experimental study. The control arm will receive the conventional hospital diet only. All the dietary intake will be recorded in patient's daily follow-up form.

Other: Conventional hospital diet

Interventions

Cooked rice starch water along with multivitamin multimineral DIETARY_SUPPLEMENT

After enrolment, a locally made formula, consisting of rice starch water, egg, multivitamins, multimineral will be administered to patients. Rice starch water is the liquid that remains after boiling rice. To prepare a moderate to thick consistency, approximately 2.5 to 3 litres of water are mixed with 1 kilogram of rice before boiling. After boiling, around 700 millilitres of moderate to thick rice starch water can be collected. After collecting rice starch water from the kitchen, egg and multivitamin, multimineral will be added by our trained health workers. The formula will be heated and blended to ensure proper mixture. Our trained health worker will involve every step and will ensure feeding within two hours of cooking. Proper hygiene will be maintained during the food preparation and distribution. In intervention arm, each patient will receive 500 ml of this liquid preparation two times daily for 14 days along with the hospital diet.

Case

Conventional hospital diet OTHER

This will be an quasi-experimental study. At National Institute of Cancer Research Hospital they use to provide patient's diet free of cost. The control arm will receive the diet that provided by the hospital for all patients. We will record all dietary intake in daily patient follow-up form.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age- ≥18 years.
• Either sex
• Diagnosed case of cancer who met Fearon et al's criteria for cancer cachexia.
• Informed written consent.

You may not qualify if:

• Patients with severe organ dysfunction, such as: renal failure (chronic kidney disease stage 4 and above), advanced hepatic failure (child-pugh score class B or C), severe cardiac dysfunction (heart failure, arrythmia, acute coronary syndrome).
• Patient with stage 4 (metastasis) cancer
• Patients with active gastrointestinal obstruction or any complication that will interfere with oral and tube feeding.
• Patient who are already getting commercially available nutritional formula or multivitamin, multimineral therapy.
• Patients with a recent history (e.g., \<3 months) of participation in another nutritional intervention study.
• Patients who require exclusive parenteral feeding.
• Patients with a known allergy to egg protein

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• National Institute of Cancer Research & Hospital, Bangladesh: collaborator

Study Sites (1)

National Institute of Cancer Research & Hospital (NICRH)

Dhaka, Mohakhali, 1212, Bangladesh

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will deploy a quasi-experimental design. The case (intervention arm) arm will receive the intervention formula along with hospital diet. The control arm will receive the hospital diet. All the dietary intake of both arm will be recorded in daily patient follow-up form

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: May 29, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

BA (1)