CompletedNot Applicable

Measurements of Resting Energy Expenditure in Patients With or at Risk of Developing Graft Versus Host Disease

United States20 participantsStarted 2005-04

Plain-language summary

This study aims to show that the MedGem indirect calorimetry measurement device will be feasible to use in children with GVHD. Also, it aims to show that children with chronic GVHD will have elevated REE that is not adequately predicted by standard equations.

Who can participate

Age range

7 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects must be 7-30 years of age * Signed informed consent * One of the following three criteria must be met: * Presence of grade II or greater acute GVHD as defined by Keystone criteria * Presence of clinically extensive chronic GVHD as defined by the revised Seattle criteria * Any subject identified prior to allogeneic transplant, or following allogeneic transplant, who is at risk for acute or chronic GVHD Exclusion Criteria: * Inability to meet the requirements of the study procedures * Any subject who is receiving supplemental oxygen * Withdrawal of consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility - can the procedure be adequately performed in a child?

Timeframe: Spring of 2010

Trial details

NCT IDNCT00600314

SponsorAnn & Robert H Lurie Children's Hospital of Chicago

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2010-09

View on ClinicalTrials.gov More Graft-Versus-Host Disease trials

Who can participate

Age range

7 Years – 30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.