Overview

This trial is active, not recruiting.

Conditions cachexia, cancer
Treatments improved atta, wheat flour, physical activity counseling, nutritional counseling
Phase phase 2/phase 3
Sponsor University of Westminster
Collaborator All India Institute of Medical Sciences, New Delhi
Start date April 2015
End date November 2015
Trial size 150 participants
Trial identifier NCT02561143, IEC/NP-339/08.10.2014

Summary

Investigators are evaluating the nutritional role of IAtta supplementation along with nutritional counselling in delaying the progression of cachexia to refractory cachexia in adult cancer Indian patients. Patients will receive IAtta (100 g) or whole wheat flour (100 g) for daily consumption for 6 months. Dietary and physical activity counseling will be imparted every fortnight to patients.

Nutritional, biochemical, quality of life and anthropometric estimations will be assessed at baseline, after 3 months and at 6 months of intervention for all patients.

Investigators hypothesize that intake of nutrient rich bread mix IAtta (along with dietary and physical activity counselling) for six months will improve the health status and quality of life in free-living patients suffering from cancer cachexia.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose supportive care
Arm
(Experimental)
Patients in the intervention group will be given dietary supplement (Improved Atta: 100 g) daily along with nutritional counseling and physical activity counseling for six months.
improved atta
Improved Atta is a multi macro- micronutrient bread mix. Patients will be given 100 grams of Improved Atta (to make unleavened bread) everyday for consumption for six months.
physical activity counseling
Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), will be encouraged daily during counseling sessions.
nutritional counseling
Dietary counseling for 30 minutes will be imparted to all patients on every hospital visits by the nutritionist. Consumption of cereals, roots and tubers, vegetables, legumes, nuts, energy dense fruits, milk products (and eggs for non-vegetarians) will be encouraged in their daily diets.
(Placebo Comparator)
Patients in the control group will be given whole wheat flour (100 g) daily along with nutritional counseling and physical activity counseling for six months.
wheat flour
Whole wheat flour 100 grams (to make unleavened bread) will be given everyday for consumption for six months to the patients.
physical activity counseling
Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), will be encouraged daily during counseling sessions.
nutritional counseling
Dietary counseling for 30 minutes will be imparted to all patients on every hospital visits by the nutritionist. Consumption of cereals, roots and tubers, vegetables, legumes, nuts, energy dense fruits, milk products (and eggs for non-vegetarians) will be encouraged in their daily diets.

Primary Outcomes

Measure
Change in body weight at 6 months
time frame: Baseline, 3 months & 6 months

Secondary Outcomes

Measure
Change in mid upper arm circumference (MUAC) at 6 months
time frame: Baseline, 3 months & 6 months
Change in body fat percentage (BF%) at 6 months
time frame: Baseline, 3 months & 6 months
Indian Migrant study food frequency questionnaire (IMS-FFQ)
time frame: Baseline, 3 months & 6 months
Two day 24 hour dietary recall
time frame: Baseline, 3 months & 6 months
Patient generated subjective global assessment (PGSGA)
time frame: Baseline, 3 months & 6 months
Indian Migrant Study Physical Activity Questionnaire (IMS-PAQ)
time frame: Baseline, 3 months & 6 months
Change in quality of life by EORTC-QLQ- C30 (Quality of life Questionnaire) at 6 months
time frame: Baseline, 3 months & 6 months
Change in haemoglobin levels at 6 months
time frame: Baseline, 3 months & 6 months
Change in serum albumin levels
time frame: Baseline, 3 months & 6 months
Change in C-reactive protein levels at 6 months
time frame: Baseline & 6 months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Female, age 18 years and above. - Diagnosed with cancer. - Weight loss >5% from pre-treatment weight or BMI<20kg/m2. - Hemoglobin level <12 g/dl. - Energy intake < 1500 kcal/d (to be assessed on consultation) Exclusion Criteria: - Incapable to provide written consent. - Patient diagnosed with refractory cachexia. - Life expectancy < 3 months. - Unresponsive to anti-cancer therapy. - Patient is a pregnant woman or a nursing mother. - Suffering from secondary illnesses. - Gastrointestinal tract defects which affect nutrient absorption.

Additional Information

Official title To Evaluate the Effectiveness of Nutritional Counselling and "Improved Atta" Supplementation in Delaying Progression of Cachexia to Refractory Cachexia in Adult Cancer Patients in Indian Population
Principal investigator Neha Kapoor, MSc
Description Patients will be randomly distributed into two groups i.e. control and intervention group. 75 patients will be allocated in intervention group and receive nutrient rich flour mix i.e. IAtta (100 g) along with dietary and physical activity counseling and 75 patients will be allocated in the control group who will receive whole wheat flour with dietary and physical activity counseling. Intervention group patients will collect 14 packets of 100 g of IAtta every fortnight during their clinician appointments while the control patients will collect 14 packets of 100 g of whole wheat flour at every clinician visit for 6 months. Dietary counseling for 30 minutes will be imparted to all patients on each visit by the nutritionist. Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), will be encouraged daily during counseling sessions. Nutritional, biochemical, quality of life and anthropometric estimations would be assessed at baseline, after 3 months and at 6 months of intervention for all patients.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Westminster.