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

University of Westminster

Status: Completed

Conditions: Cachexia; Cancer

Treatments: Dietary Supplement: Wheat flour; Dietary Supplement: Improved Atta; Behavioral: Physical activity counseling; Other: Nutritional counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT02561143

IEC/NP-339/08.10.2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups, including a placebo group

Intervention group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Improved Atta

Other: Nutritional counseling

Behavioral: Physical activity counseling

Control group

Placebo Comparator group

Description:

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.

Treatment:

Other: Nutritional counseling

Dietary Supplement: Wheat flour

Behavioral: Physical activity counseling