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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Westminster
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Change in body weight at 6 months
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female, age 18 years and above.
- •Diagnosed with cancer.
- •Weight loss >5% from pre-treatment weight or BMI<20kg/m
- •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.
Arms & Interventions
Intervention group
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.
Intervention: Improved Atta (Dietary Supplement)
Intervention group
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.
Intervention: Physical activity counseling (Behavioral)
Intervention group
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.
Intervention: Nutritional counseling (Other)
Control group
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.
Intervention: Physical activity counseling (Behavioral)
Control group
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.
Intervention: Nutritional counseling (Other)
Control group
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.
Intervention: Wheat flour (Dietary Supplement)
Outcomes
Primary Outcomes
Change in body weight at 6 months
Time Frame: Baseline, 3 months & 6 months
Body weight in kilograms will be assessed using a Tanita segmental composition scale at baseline, mid-intervention (3 months) and at the end of intervention (6 months).
Secondary Outcomes
- Change in body fat percentage (BF%) at 6 months(Baseline, 3 months & 6 months)
- Change in mid upper arm circumference (MUAC) at 6 months(Baseline, 3 months & 6 months)
- Change in haemoglobin levels at 6 months(Baseline, 3 months & 6 months)
- Indian Migrant Study Physical Activity Questionnaire (IMS-PAQ)(Baseline, 3 months & 6 months)
- Change in serum albumin levels(Baseline, 3 months & 6 months)
- Indian Migrant study food frequency questionnaire (IMS-FFQ)(Baseline, 3 months & 6 months)
- Two day 24 hour dietary recall(Baseline, 3 months & 6 months)
- Patient generated subjective global assessment (PGSGA)(Baseline, 3 months & 6 months)
- Change in quality of life by EORTC-QLQ- C30 (Quality of life Questionnaire) at 6 months(Baseline, 3 months & 6 months)
- Change in C-reactive protein levels at 6 months(Baseline & 6 months)
Investigators
Neha Kapoor
Research Scholar
University of Westminster