Clinical trial NCT02734797: Clinical Outcomes, Nutritional Status, Exercise and Psychosocial Factors in Pediatric Hematopoietic Cell Transplant
Official title: Clinical Outcomes, Nutritional Status, Exercise and Psychosocial Factors in Pediatric Hematopoietic Cell Transplant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition
Obesity
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 55
Sex: ALL
Minimum age (years): 2
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric hematopoietic cell transplant patients

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of comprehensive nutrition assessments in pediatric HCT patients
timeFrame: 1 year post-HCT
Secondary outcomes:
measure: Dietary intake
timeFrame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
measure: Determination of lean body mass measured using air displacement plethysmography (BOD POD)
timeFrame: baseline (pre-HCT); day 100 and 1 year post-HCT
measure: Hand grip strength
timeFrame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
measure: PedsQL Pediatric Quality of Life Inventory
timeFrame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
measure: PedsQL Cognitive Functioning Scale
timeFrame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
measure: Dietary Patient Self-Efficacy Survey
timeFrame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
References: