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

NCT02734797 | Completed DMC

• 2 other identifiers: UMCC 2015.108HUM00102331
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition; Obesity

Outcome Measures

Primary Outcomes (1)

• Feasibility of comprehensive nutrition assessments in pediatric HCT patients

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

  1 year post-HCT

Secondary Outcomes (6)

• Dietary intake

  baseline (pre-HCT); day 30, day 100 and 1 year post-HCT

• 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

• PedsQL Pediatric Quality of Life Inventory

  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

Study Arms (1)

Pediatric patients

This is an observational study. Validated measures of nutritional status, dietary intake, body composition, functional status and psychosocial factors will be used to measure outcomes in study patients at 4 time-points: (1) pre-HCT (Baseline), (2) 30-days post-HCT, (3) 100-days post-HCT and (4) one year post-HCT.

Eligibility Criteria

• Age: 2 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric hematopoietic cell transplant patients

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Malnutrition; Obesity

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: April 12, 2016
• Study Start: March 9, 2016
• Primary Completion: February 10, 2020
• Study Completion: February 10, 2020
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)