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

Completed

• Conditions: Malnutrition; Obesity

• Registration Number: NCT02734797
• Lead Sponsor: University of Michigan Rogel Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-09
• Study First Submitted: 2016-03-17
• Study First Submitted QC: 2016-04-05
• Study First Posted: 2016-04-12
• Primary Completion: 2020-02-10
• Study Completion: 2020-02-10
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of comprehensive nutrition assessments in pediatric HCT patients	1 year post-HCT	Feasibility is defined as completion of comprehensive nutrition assessment by at least 50% of participants.

Secondary Outcome Measures

Name	Time	Method
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	Participants 10 years or older
Dietary Patient Self-Efficacy Survey	baseline (pre-HCT); day 30, day 100 and 1 year post-HCT	Participants 10 years or older
PedsQL Cognitive Functioning Scale	baseline (pre-HCT); day 30, day 100 and 1 year post-HCT	Participants 10 years or older

Trial Locations

Locations (1)

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States