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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02561143
Other study ID # IEC/NP-339/08.10.2014
Secondary ID
Status Completed
Phase N/A
First received September 21, 2015
Last updated June 21, 2017
Start date April 2015
Est. completion date May 2016

Study information

Verified date June 2017
Source University of Westminster
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date May 2016
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
India All India Institute of Medical Sciences New Delhi
United Kingdom University of Westminster London

Sponsors (2)

Lead Sponsor Collaborator
University of Westminster All India Institute of Medical Sciences, New Delhi

Countries where clinical trial is conducted

India,  United Kingdom, 

References & 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.

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in mid upper arm circumference (MUAC) at 6 months MUAC in centimeters will be measured using a non-stretchable measuring tape at baseline, mid-intervention (3 months) and at the end of intervention (6 months). Baseline, 3 months & 6 months
Secondary Change in body fat percentage (BF%) at 6 months Four site skin fold thickness (SFT) measurement (i.e. triceps, biceps, subscapular and suprailiac) by the help of scientific Harpenden Skinfold Caliper will be noted to the nearest 0.2mm reading, to calculate percentage body density. Body fat percentage will be calculated using body density value in Siri equation.
SFT will be measured at baseline, mid-intervention (3 months) and end of intervention (6 months) to determine the BF%.
Baseline, 3 months & 6 months
Secondary Indian Migrant study food frequency questionnaire (IMS-FFQ) IMS-FFQ will be used to assess patient's daily energy (kcal), protein (g) and fat (g) intake at baseline, mid-intervention and end of intervention (6 months).
Food frequency questionnaire is an accurate method to record the frequency of consumption of individual foods and can help provide information on patients' eating patterns. IMS-FFQ (Indian Migrant Study- Food Frequency Questionnaire) consists of 184 commonly consumed food items and is validated among the rural and urban Indian population.
Baseline, 3 months & 6 months
Secondary Two day 24 hour dietary recall Two day 24 hour dietary recall will be used to assess patient's daily energy (kcal), protein (g) and fat (g) intake at baseline, mid-intervention and end of intervention (6 months).
24 hour dietary recall is an accurate method to understand patients' eating patterns.
Baseline, 3 months & 6 months
Secondary Patient generated subjective global assessment (PGSGA) PGSGA will be used to assess patient nutritional status (category: well nourished, malnourished & severely malnourished) at baseline, mid-intervention and end of intervention (6 months).
PG-SGA is most effective and sensitive tool for assessing and evaluating cancer patients' nutritional status and validated on Indian cancer patients.
Baseline, 3 months & 6 months
Secondary Indian Migrant Study Physical Activity Questionnaire (IMS-PAQ) IMS-PAQ will assess patients' physical activity throughout the day. Investigators will asses physical activity at three time points during the study: baseline, at 3 months of intervention and at 6 months end of intervention. IMS-PAQ is a validated questionnaire on both Indian rural and urban population. Patients' will report every activity performed with the average amount of time spent for each activity in the questionnaire. Thereafter, investigators will calculate the average calories spent by every patient in the whole day. Baseline, 3 months & 6 months
Secondary Change in quality of life by EORTC-QLQ- C30 (Quality of life Questionnaire) at 6 months EORTC-QLQ- C30 (European Organization for Research &Treatment of cancer) questionnaire will be used to analyse patients' quality of life at baseline, mid- intervention and at the end of intervention period. A score will be calculated for all the15 domains covered in the questionnaire of 30 questions.These domains will be analysed and compared for the outcome in the two groups. Baseline, 3 months & 6 months
Secondary Change in haemoglobin levels at 6 months Haemoglobin levels (g/dl) will be monitored at baseline, at three months and at the end of intervention (6 months). Baseline, 3 months & 6 months
Secondary Change in serum albumin levels Serum albumin (g%) levels will be monitored at baseline, at three months and at the end of intervention (6 months). Baseline, 3 months & 6 months
Secondary Change in C-reactive protein levels at 6 months C-reactive protein (mg/L) levels will be monitored at baseline and at the end of intervention (6 months). Baseline & 6 months
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