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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02561143
• Other study ID #: IEC/NP-339/08.10.2014
• 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
• 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.

Related Conditions & MeSH terms

• Cachexia
• Cancer

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