To assess the acceptance of the micronutrient sprinkler formulations in pediatric patients with cancer.
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- IIT Bombay
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Acceptance of the sprinkler formulation(s), assessed through a Likert scale
研究概览
简要总结
This study aims to see if improving nutrition can help undernourished children with cancer do better during treatment. Specifically, it will test if giving them a special food supplement with the right amounts of protein, calories, vitamins, and minerals can help them handle chemotherapy, reduce health issues, and improve their chances of survival. The study will focus on children in need, particularly in less developed countries. For 10 days, 30 children will take part in the study. The children will be given a daily 40-gram food supplement, divided into four small servings throughout the day. The supplement comes in four flavors: Maggie masala, chocolate, chat masala, and unflavored. In the first 3 days, all flavors will be given to the children. After that, parents will help their child pick their two favorite flavors to continue with. A dietitian will closely monitor the children’s health, and parents will fill out a simple questionnaire about how the child likes the food, as well as keep a diary of any reactions or changes they notice. Nutritional assessments will be done on the first and last day of the study to check for improvements, and blood samples will also be taken to study how the supplement affects the children’s bodies. Throughout the study, the parents will be kept informed and supported by the study team. The goal is to gather valuable information on how nutrition can improve cancer treatment outcomes for these children and acceptability of the formulation by children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 4.00 Year(s) 至 12.00 Year(s)(—)
- 性别
- All
入选标准
- •1 Children aged between 4 to 12 years and diagnosed with solid tumors 2 Patients receiving active treatment (chemotherapy -radiation) 3 Receiving treatment at Tata Memorial Hospital Parel.
排除标准
- •1 Presence of grade-3 or more adverse events, specifically nausea, vomiting and diarrhea 2 Refusal of informed consent 3 Patients on nasogastric tube feeds 4 Patients with any food allergies.
结局指标
主要结局
Acceptance of the sprinkler formulation(s), assessed through a Likert scale
时间窗: Likert scale assessment will be conducted on Day 3 to identify the two most preferred flavours to be given until day 10.
次要结局
- 1. Palatability: Taste, texture, and overall acceptability of the supplement to pediatric patients.(2. Compliance: Assess how well patients adhere to the prescribed regimen of the supplements)
研究者
Dr MAYA PRASAD
Tata Memorial Hospital
