跳至主要内容
临床试验/CTRI/2025/08/092312
CTRI/2025/08/092312尚未招募1/2 期

To assess the acceptance of the micronutrient sprinkler formulations in pediatric patients with cancer.

IIT Bombay1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月20日最近更新:

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

发起方
IIT Bombay
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr MAYA PRASAD

Tata Memorial Hospital

研究点 (1)

Loading locations...

相似试验