Clinical trial NCT02561143: Effectiveness of Nutritional Counselling and "Improved Atta" Supplementation in Cachexic Adult Indian Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cachexia
Cancer
Keywords: cachexia
nutrition supplementation
IAtta
palliative care
quality of life
Lead sponsor: University of Westminster
Sponsor class: OTHER
Collaborators: name: All India Institute of Medical Sciences
First posted: 2015-09-25
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in body weight at 6 months
timeFrame: Baseline, 3 months & 6 months
Secondary outcomes:
measure: Change in mid upper arm circumference (MUAC) at 6 months
timeFrame: Baseline, 3 months & 6 months
measure: Change in body fat percentage (BF%) at 6 months
timeFrame: Baseline, 3 months & 6 months
measure: Indian Migrant study food frequency questionnaire (IMS-FFQ)
timeFrame: Baseline, 3 months & 6 months
measure: Two day 24 hour dietary recall
timeFrame: Baseline, 3 months & 6 months
measure: Patient generated subjective global assessment (PGSGA)
timeFrame: Baseline, 3 months & 6 months
measure: Indian Migrant Study Physical Activity Questionnaire (IMS-PAQ)
timeFrame: Baseline, 3 months & 6 months
measure: Change in quality of life by EORTC-QLQ- C30 (Quality of life Questionnaire) at 6 months
timeFrame: Baseline, 3 months & 6 months
measure: Change in haemoglobin levels at 6 months
timeFrame: Baseline, 3 months & 6 months
measure: Change in serum albumin levels
timeFrame: Baseline, 3 months & 6 months
measure: Change in C-reactive protein levels at 6 months
timeFrame: Baseline & 6 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
city: London
country: United Kingdom
facility: University of Westminster
Study officials:
affiliation: University of Westminster
name: Neha Kapoor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Westminster
name: Ihab Tewfik, PhD
role: STUDY_DIRECTOR
References:
citation: 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.