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

Obesity Clinical Trial

— CONSEPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02734797
• Other study ID #: UMCC 2015.108
• Secondary ID: HUM00102331
• Status: Completed
• Start date: March 9, 2016
• Est. completion date: February 10, 2020

Study information

• Verified date: January 2024
• Source: University of Michigan Rogel Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: February 10, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition
• Obesity

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Dietary intake		baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
Secondary	Determination of lean body mass measured using air displacement plethysmography (BOD POD)		baseline (pre-HCT); day 100 and 1 year post-HCT
Secondary	Hand grip strength		baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
Secondary	PedsQL Pediatric Quality of Life Inventory	Participants 10 years or older	baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
Secondary	PedsQL Cognitive Functioning Scale	Participants 10 years or older	baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
Secondary	Dietary Patient Self-Efficacy Survey	Participants 10 years or older	baseline (pre-HCT); day 30, day 100 and 1 year post-HCT