Clinical Trial: Effectiveness of Nutritional Counselling and "Improved Atta" Supplementation in Cachexic Adult Indian Cancer Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Pop
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 Summary:
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.
Sponsor: University of Westminster
Current Primary Outcome: Change in body weight at 6 months [ Time Frame: Baseline, 3 months & 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in mid upper arm circumference (MUAC) at 6 months [ Time Frame: Baseline, 3 months & 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).
- Change in body fat percentage (BF%) at 6 months [ Time Frame: Baseline, 3 months & 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%.
- Indian Migrant study food frequency questionnaire (IMS-FFQ) [ Time Frame: Baseline, 3 months & 6 months ]
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 [ Time Frame: Baseline, 3 months & 6 months ]
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.
- Patient generated subjective global assessment (PGSGA) [ Time Frame: Baseline, 3 months & 6 months ]
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.
- Indian Migrant Study Physical Activity Questionnaire (IMS-PAQ) [ Time Frame: Baseline, 3 months & 6 months ]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.
- Change in quality of life by EORTC-QLQ- C30 (Quality of life Questionnaire) at 6 months [ Time Frame: Baseline, 3 months & 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.
- Change in haemoglobin levels at 6 months [ Time Frame: Baseline, 3 months & 6 months ]Haemoglobin levels (g/dl) will be monitored at baseline, at three months and at the end of intervention (6 months).
- Change in serum albumin levels [ Time Frame: Baseline, 3 months & 6 months ]Serum albumin (g%) levels will be monitored at baseline, at three months and at the end of intervention (6 months).
- Change in C-reactive protein levels at 6 months [ Time Frame: Baseline & 6 months ]C-reactive protein (mg/L) levels will be monitored at baseline and at the end of intervention (6 months).
Original Secondary Outcome: Same as current
Information By: University of Westminster
Dates:
Date Received: September 21, 2015
Date Started: April 2015
Date Completion:
Last Updated: March 31, 2017
Last Verified: March 2017
