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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 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.

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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.

Conditions Studied

Study Locations (1)

Michigan

  • University of Michigan Health System - Ann Arbor

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2016-03-09
Est. Completion 2020-02-10

What the Registry Record Tells You About NCT02734797

The ClinicalTrials.gov registry entry for NCT02734797 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (93% lower). The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 0 interventions.

NCT02734797 reports 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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