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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02734797
Acronym
CONSEPT
Enrollment
55
Registered
2016-04-12
Start date
2016-03-09
Completion date
2020-02-10
Last updated
2024-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition, Obesity

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.

Interventions

None listed

Sponsors

University of Michigan Rogel Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 25 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of comprehensive nutrition assessments in pediatric HCT patients1 year post-HCTFeasibility is defined as completion of comprehensive nutrition assessment by at least 50% of participants.

Secondary

MeasureTime frameDescription
Determination of lean body mass measured using air displacement plethysmography (BOD POD)baseline (pre-HCT); day 100 and 1 year post-HCT
Hand grip strengthbaseline (pre-HCT); day 30, day 100 and 1 year post-HCT
Dietary intakebaseline (pre-HCT); day 30, day 100 and 1 year post-HCT
PedsQL Cognitive Functioning Scalebaseline (pre-HCT); day 30, day 100 and 1 year post-HCTParticipants 10 years or older
Dietary Patient Self-Efficacy Surveybaseline (pre-HCT); day 30, day 100 and 1 year post-HCTParticipants 10 years or older
PedsQL Pediatric Quality of Life Inventorybaseline (pre-HCT); day 30, day 100 and 1 year post-HCTParticipants 10 years or older

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026