Symptoms and General Pathology

All Conditions

Nutritional and Metabolic Diseases

Behaviors and Mental Disorders

Disease Progression

Wasting Syndrome

Cachexia

Syndrome

Weight Loss

Body Weight

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

Quality of Life

Micronutrients

All Drugs and Chemicals

Trace Elements

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.

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.

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.

Improved Atta

Whole wheat flour 100 grams (to make unleavened bread) will be given everyday for consumption for six months to the patients.

Wheat flour

Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), will be encouraged daily during counseling sessions.

Physical activity 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.

Nutritional counseling

Neha Kapoor, PhD

Ihab Tewfik, PhD

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.

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.

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

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).

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).

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%.

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.

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.

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.

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.

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.

Haemoglobin levels (g/dl) will be monitored at baseline, at three months and at the end of intervention (6 months).

Serum albumin (g%) levels will be monitored at baseline, at three months and at the end of intervention (6 months).

C-reactive protein (mg/L) levels will be monitored at baseline and at the end of intervention (6 months).

All India Institute of Medical Sciences, New Delhi

University of Westminster

Research Scholar

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.

Patients in the control group were given nutritional and physical activity counseling for six months every fortnight.

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.

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.

Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), was encouraged daily during counseling sessions.

The main aim of the study is to assess the effectiveness of tailored nutritional intervention in delaying the progression of cachexia to refractory cachexia in adult female cancer patients.

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.

Patients were randomly distributed into two groups i.e. control and intervention group. 30 patients were allocated in intervention group and received nutrient rich bread mix i.e. IAtta (100 g) along with dietary and physical activity counseling and 33 patients were allocated in the control group who received only dietary and physical activity counseling. Patients in the intervention group collected 14 packets of 100 g of IAtta every fortnight during their clinician appointments while the control patients were advised regarding their dietary habits at every clinician visit for 6 months.

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).

Impact of Nutritional Intervention in Indian Female Cancer Cachexia Patients

To Study the Impact of Nutritional Intervention in Delaying the Progression of Cachexia to Refractory Cachexia in Female Cancer Patients: A Study Based in India

Body weight was assessed using a Tanita segmental composition scale at baseline, mid-intervention (3 months) and at the end of intervention (6 months).

MUAC was measured using a non-stretchable measuring tape at baseline, mid-intervention (3 months) and at the end of intervention (6 months).

Four site skin fold thickness (SFT) measurement (i.e. triceps, biceps, subscapular and suprailiac) by the help of scientific Harpenden Skinfold Caliper was noted to the nearest 0.2mm reading, to calculate percentage body density. Body fat percentage was calculated using body density value in Siri equation. SFT was measured at baseline, mid-intervention (3 months) and end of intervention (6 months) to determine the BF%.

Indian Migrant study food frequency questionnaire (IMS-FFQ), two day 24 hour dietary recall and patient generated subjective global assessment were used to assess patient nutritional status at baseline, mid-intervention and end of intervention (6 months).

Food frequency questionnaire and 24 hour dietary recall is an accurate method to record the frequency of consumption of individual foods and can help provide information on patients' eating patterns.IMS-FFQ consists of 184 commonly consumed food items and was validated among the rural and urban Indian population. PG-SGA is most effective and sensitive tool for assessing and evaluating cancer patients' nutritional status and validated on Indian cancer patients.

Indian Migrant Study Physical Activity questionnaire (IMS-PAQ) was used to assess patients' physical activity throughout the day. We assessed 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.

EORTC-QLQ- C30 questionnaire was used to analyse patients' QoL at baseline, mid- intervention and at the end of intervention period.

Haemoglobin levels were monitored at baseline, at three months and at the end of intervention (6 months).

Serum albumin levels were monitored at baseline, at three months and at the end of intervention (6 months).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effectiveness of Nutritional Counselling and "Improved Atta" Supplementation in Cachexic Adult Indian Cancer Patients	NCT02561143	Cachexia Cancer	Improved Atta Wheat flour Physical activi... Nutritional cou...	18 Years -	University of Westminster
Impact of Nutritional Intervention in Indian Female Cancer Cachexia Patients	NCT02350855	Cachexia Cancer	Improved Atta Nutritional cou... Physical activi...	18 Years -	University of Westminster
Impact of Nutritional Intervention in Indian Female Cancer Cachexia Patients	NCT02350855	Cachexia Cancer	Improved Atta Nutritional cou... Physical activi...	18 Years -	University of Westminster
Effectiveness of Nutritional Counselling and "Improved Atta" Supplementation in Cachexic Adult Indian Cancer Patients	NCT02561143	Cachexia Cancer	Improved Atta Wheat flour Physical activi... Nutritional cou...	18 Years -	University of Westminster

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