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

NCT ID: NCT02561143

Last Updated: 2017-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-05-31

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.

Conditions

Cachexia; Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Improved Atta

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: BEHAVIORAL

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

Intervention Type: OTHER

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.

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.

Group Type: PLACEBO_COMPARATOR

Wheat flour

Intervention Type: DIETARY_SUPPLEMENT

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

Physical activity counseling

Intervention Type: BEHAVIORAL

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

All India Institute of Medical Sciences

OTHER

Sponsor Role: collaborator

University of Westminster

OTHER

Sponsor Role: lead

Responsible Party

Neha Kapoor

Research Scholar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neha Kapoor, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Westminster

Ihab Tewfik, PhD

Role: STUDY_DIRECTOR

University of Westminster

Locations

All India Institute of Medical Sciences

New Delhi, , India

University of Westminster

London, , United Kingdom

Countries

India; United Kingdom

References

Kapoor N, Naufahu J, Tewfik S, Bhatnagar S, Garg R, Tewfik I. A public health nutrition intervention to delay the progression of cachexia to refractory cachexia in indian female cancer patients. Int. J. Food, Nutrition and Public Health. 2014;7:1-11.

Reference Type: BACKGROUND

Other Identifiers

IEC/NP-339/08.10.2014

Identifier Type: -

Identifier Source: org_study_id