Impact of Nutritional Intervention in Indian Female Cancer Cachexia Patients
NCT ID: NCT02350855
Last Updated: 2015-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
62 participants
INTERVENTIONAL
2013-12-31
2014-08-31
Brief Summary
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The tested hypothesis stated that intake of nutrient rich bread mix (along with dietary and physical activity counselling) for six months, improved the anthropometric and biochemical indices in free-living patients suffering from cancer cachexia.
Detailed Description
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Dietary counseling for 30 minutes was imparted to all patients on each visit by the researcher. Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), was encouraged daily during counseling sessions.
Nutritional, biochemical, quality of life and anthropometric estimations were assessed at baseline, after 3 months and at 6 months of intervention for all patients.
Patients' daily energy, carbohydrate, protein and fat intake were calculated using food frequency (Indian Migrant study food frequency questionnaire- IMS-FFQ) questionnaire and two day 24 hour recall data. PG-SGA questionnaire was used to monitor patient nutritional status throughout the study.
EORTC-QLQ- C30 questionnaire was used to analyse patients' quality of life and asked personally by the researcher.
Haemoglobin and serum albumin levels were assessed at the start of the study, after 3 months and at 6 months of intervention for all patients.
Indian Migrant Study Physical Activity questionnaire (IMS-PAQ) was used to assess patients' physical activity throughout the day.
Anthropometric estimations included body weight, mid upper arm circumference and four site skin fold thickness (SFT) measurement (i.e. triceps, biceps, subscapular and suprailiac).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention group
Patients in the intervention group were given dietary supplement (Improved Atta: 100 g) daily along with nutritional counseling and physical activity counseling for six months.
Improved Atta
Improved Atta is a multi macro- micronutrient bread mix. Patients were given 100 grams of Improved Atta (in the from of unleavened bread) everyday for consumption for six months.
Nutritional counseling
Dietary counseling for 30 minutes was imparted to all patients on every hospital visits by the researcher. Consumption of cereals, roots and tubers, vegetables, legumes, nuts, energy dense fruits, milk products (and eggs for non-vegetarians) was encouraged in their daily diets.
Physical activity counseling
Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), was encouraged daily during counseling sessions.
Control group
Patients in the control group were given nutritional and physical activity counseling for six months every fortnight.
Nutritional counseling
Dietary counseling for 30 minutes was imparted to all patients on every hospital visits by the researcher. Consumption of cereals, roots and tubers, vegetables, legumes, nuts, energy dense fruits, milk products (and eggs for non-vegetarians) was encouraged in their daily diets.
Physical activity counseling
Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), was encouraged daily during counseling sessions.
Interventions
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Improved Atta
Improved Atta is a multi macro- micronutrient bread mix. Patients were given 100 grams of Improved Atta (in the from of unleavened bread) everyday for consumption for six months.
Nutritional counseling
Dietary counseling for 30 minutes was imparted to all patients on every hospital visits by the researcher. Consumption of cereals, roots and tubers, vegetables, legumes, nuts, energy dense fruits, milk products (and eggs for non-vegetarians) was encouraged in their daily diets.
Physical activity counseling
Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), was encouraged daily during counseling sessions.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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All India Institute of Medical Sciences
OTHER
University of Westminster
OTHER
Responsible Party
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Neha Kapoor
Research Scholar
Principal Investigators
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Ihab Tewfik, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Westminster
Locations
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All India Institute of Medical Sciences
New Delhi, , India
University of Westminster
London, , United Kingdom
Countries
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References
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Kapoor N, Naufahu J, Tewfik S, Bhatnagar S, Garg R, Tewfik I. A Prospective Randomized Controlled Trial to Study the Impact of a Nutrition-Sensitive Intervention on Adult Women With Cancer Cachexia Undergoing Palliative Care in India. Integr Cancer Ther. 2017 Mar;16(1):74-84. doi: 10.1177/1534735416651968. Epub 2016 Jun 1.
Other Identifiers
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12_13_11
Identifier Type: -
Identifier Source: org_study_id