Effectiveness of Nutritional Counselling and "Improved Atta" Supplementation in Cachexic Adult Indian Cancer Patients

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.

Conditions

• Cachexia
• Cancer

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

Wheat flour

Whole wheat flour 100 grams (to make unleavened bread) will be given everyday for consumption for six months to the patients.

BEHAVIORAL

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.

OTHER

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.

Sponsors & Collaborators

• All India Institute of Medical Sciences

  collaborator OTHER

• University of Westminster

  lead OTHER

Principal Investigators

• Neha Kapoor, PhD · University of Westminster

• Ihab Tewfik, PhD · University of Westminster

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-30

Primary Completion

2015-11-30

Completion

2016-05-31

Countries

• India
• United Kingdom

Study Locations