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OpenTrials
Completed

NCT Number: NCT02734797

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 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.

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Key information

Age range

2 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Feasibility of comprehensive nutrition assessments in pediatric HCT patients

    Time frame: 1 year post-HCT

    Feasibility is defined as completion of comprehensive nutrition assessment by at least 50% of participants.

Secondary outcomes

  1. Dietary intake

    Time frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT

  2. Determination of lean body mass measured using air displacement plethysmography (BOD POD)

    Time frame: baseline (pre-HCT); day 100 and 1 year post-HCT

  3. Hand grip strength

    Time frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT

  4. PedsQL Pediatric Quality of Life Inventory

    Time frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT

    Participants 10 years or older

  5. PedsQL Cognitive Functioning Scale

    Time frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT

    Participants 10 years or older

  6. Dietary Patient Self-Efficacy Survey

    Time frame: baseline (pre-HCT); day 30, day 100 and 1 year post-HCT

    Participants 10 years or older

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Acronym: CONSEPT

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 12, 2016
Registry last updated
Jan 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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