跳至主要内容
临床试验/NCT02734797
NCT02734797已完成不适用

Clinical Outcomes, Nutritional Status, Exercise and Psychosocial Factors in Pediatric Hematopoietic Cell Transplant

University of Michigan Rogel Cancer Center1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2016年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
1
主要终点
Feasibility of comprehensive nutrition assessments in pediatric HCT patients

研究概览

简要总结

Children who receive hematopoietic cell transplants (HCT) are at high nutritional risk due to comorbidities and complications that are likely to develop before, during and after transplant. Prior to transplant, many children undergo multiple rounds of chemotherapy which affect appetite and cause gastrointestinal toxicities that limit food intake. During transplant, painful mucositis makes it difficult to consume adequate nutrients and often children will require nutrition support such as parenteral or enteral nutrition. Energy imbalance and physical deconditioning following transplant can result in loss of lean body mass and functional impairment; these nutritional side effects are exacerbated if the child develops graft-versus-host disease. After transplant, a substantial number of childhood cancer survivors become overweight and develop metabolic syndrome. However, little is known about the prevalence and distribution of pediatric malnutrition (under-nutrition as well as obesity), the psychosocial factors that affect dietary intake and how the quality of the child's food intake and physical activity level throughout the transplant process might affect body composition and clinical outcomes. In this exploratory study, we will monitor nutritional status in pediatric patients undergoing HCT. This study will test the feasibility of collecting patient-reported dietary intake data along with anthropometric, body composition, functional status and psychosocial measurements that may influence dietary intake in pediatric patients undergoing HCT. The data collected in this preliminary analysis will inform future interventional studies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pediatric hematopoietic cell transplant patients, aged 2-25 years.
  • Participants and/or at least one caregiver must speak, read and understand English.

排除标准

  • Children younger than 2 years old at the time of their transplant or any child who is still breastfeeding will not be eligible due to the nature of the questionnaires and measurements.

结局指标

主要结局

Feasibility of comprehensive nutrition assessments in pediatric HCT patients

时间窗: 1 year post-HCT

Feasibility is defined as completion of comprehensive nutrition assessment by at least 50% of participants.

次要结局

  • Determination of lean body mass measured using air displacement plethysmography (BOD POD)(baseline (pre-HCT); day 100 and 1 year post-HCT)
  • Hand grip strength(baseline (pre-HCT); day 30, day 100 and 1 year post-HCT)
  • Dietary intake(baseline (pre-HCT); day 30, day 100 and 1 year post-HCT)
  • PedsQL Pediatric Quality of Life Inventory(baseline (pre-HCT); day 30, day 100 and 1 year post-HCT)
  • Dietary Patient Self-Efficacy Survey(baseline (pre-HCT); day 30, day 100 and 1 year post-HCT)
  • PedsQL Cognitive Functioning Scale(baseline (pre-HCT); day 30, day 100 and 1 year post-HCT)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验