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NCT02734797 · ClinicalTrials.gov registry record
Clinical Outcomes, Nutritional Status, Exercise and Psychosocial Factors in Pediatric Hematopoietic Cell Transplant
A clinical trial of Obesity and Malnutrition, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- 55
- Enrollment target
- 1
- Study location
NCT02734797: Completed study of Obesity and Malnutrition, sponsored by University of Michigan Rogel Cancer Center.
NCT02734797 is a study of Obesity and Malnutrition that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 55 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02734797, a study of Obesity and Malnutrition, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- 55 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Feasibility is defined as completion of comprehensive nutrition assessment by at least 50% of participants.
Conditions Studied
Study Locations (1)
Michigan
- University of Michigan Health System - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2016-03-09 |
| Est. Completion | 2020-02-10 |
What the finished NCT02734797 record still lists
NCT02734797 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 0 interventions.
NCT02734797 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT02734797 about?
NCT02734797 is a clinical study titled "Clinical Outcomes, Nutritional Status, Exercise and Psychosocial Factors in Pediatric Hematopoietic Cell Transplant". 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 gas...
What is the current status of trial NCT02734797?
This trial is currently completed. The enrollment target is 55 participants. The study started on 2016-03-09. Estimated completion is 2020-02-10.
What conditions does trial NCT02734797 study?
This clinical trial studies the following conditions: Obesity, Malnutrition.
Who is sponsoring clinical trial NCT02734797?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02734797 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02734797's enrollment target sits among peer trials
55 695th of 1053 higher than 358 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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