Effectiveness of Nutritional Counselling and "Improved Atta" Supplementation in Cachexic Adult Indian Cancer Patients
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
1 other identifier
interventional
150
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 21, 2015
CompletedFirst Posted
Study publicly available on registry
September 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJune 22, 2017
June 1, 2017
7 months
September 21, 2015
June 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in body weight at 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).
Baseline, 3 months & 6 months
Secondary Outcomes (10)
Change in mid upper arm circumference (MUAC) at 6 months
Baseline, 3 months & 6 months
Change in body fat percentage (BF%) at 6 months
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
- +5 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALPatients 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.
Control group
PLACEBO COMPARATORPatients in the control group will be given whole wheat flour (100 g) daily along with nutritional counseling and physical activity counseling for six months.
Interventions
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.
Whole wheat flour 100 grams (to make unleavened bread) will be given everyday for consumption for six months to the patients.
Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), will be encouraged daily during counseling sessions.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Westminsterlead
- All India Institute of Medical Sciencescollaborator
Study Sites (2)
All India Institute of Medical Sciences
New Delhi, 110029, India
University of Westminster
London, W1W 6UW, United Kingdom
Related Publications (1)
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.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neha Kapoor, PhD
University of Westminster
- STUDY DIRECTOR
Ihab Tewfik, PhD
University of Westminster
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Scholar
Study Record Dates
First Submitted
September 21, 2015
First Posted
September 25, 2015
Study Start
April 1, 2015
Primary Completion
November 1, 2015
Study Completion
May 1, 2016
Last Updated
June 22, 2017
Record last verified: 2017-06