Health Condition 1: null- Newly registered treatment naïve malnourished children diagnosed with cancer.
Conditions
Interventions
Intervention1: NA: NA
Control Intervention1: Standard of care (usual dietary care) including supplementation with home based and commercial supplements: NA
Sponsors
UNICEF and Nutrition Rehabilitation Research Centre
Cuddles Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed children with cancer 2. Age : 2-15 years 3. Malnutrition: Weight-for- Age <90% IBW, or mid-arm circumference <10th Percentile for age or BMI for age < -1 SD)and a good appetite based on oral inake& appetite screening test
Exclusion criteria
Exclusion criteria: 1. Tumors involving pharynx or likely to receive RT to head/neck region 2. Children judged to be too ill to participate at the discretion of the attending physician (including intractable vomiting, diarrhea, mucositis, severe infections, hemodynamic instability).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of percent of subjects who gain weight (5% weight gain compared to baseline) in both arms.Timepoint: Assessments will be done at baseline, at 2 weeks, after 6 weeks and then monthly for 6 months. Assessments would be done on basis of nutritional history, Anthropometric measurements, Biochemical and Micronutrient Status, Clinical Morbidity and Mortality and QOL | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the Micro-nutrients in the childrenâ?¢ Incidence & duration of febrile neutropenia , admissions, protocol violations, toxicity-related deaths in arms Comparison of health-related quality of life improvement in 2 arms Relative changes in the body composition in arms for lean mass and fat content Difference in the cost of care in 2 armsTimepoint: Assessments will be done at baseline, at 2 weeks, after 6 weeks and then monthly for 6 months. Assessments would be done on basis of nutritional history, Anthropometric measurements, Biochemical and Micronutrient Status, Clinical Morbidity and Mortality and QOL;Comparison of percent of subjects in 2 arms who maintain BMI& weight in both arms ( prevention of weight loss on chemotherapy) Timepoint: Assessments will be done at baseline, at 2 weeks, after 6 weeks and then monthly for 6 months. Assessments would be done on basis of nutritional history, Anthropometric measurements, Biochemical and Micronutrient Status, Clinical Morbidity and Mortality and QOL | — |
Countries
India
Contacts
Public ContactDr Brijesh Arora
Tata Memorial Hospital
Outcome results
None listed