Using hyperbaric oxygen therapy to treat acute graft-versus-host disease
Hyperbaric Oxygen Therapy Improve Acute Graft-Versus-Host Disease in Patients Underwent Allogeneic Hematopoietic Stem Cell Transplantation
This study is testing if hyperbaric oxygen therapy can help patients with acute graft-versus-host disease feel better after receiving a stem cell transplant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Shandong Provincial Hospital Government |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT05078073 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of hyperbaric oxygen therapy (HBOT) for patients who develop acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT). The study is designed as a randomized, controlled, and open clinical trial, aiming to provide a new therapeutic strategy for managing aGVHD, which is a significant barrier to long-term survival in transplant recipients. By targeting reactive oxygen species, the trial seeks to improve patient outcomes and reduce inflammation associated with aGVHD.
Who should consider this trial
Good fit: Ideal candidates for this study are patients undergoing allogeneic stem cell transplantation who have developed acute graft-versus-host disease.
Not a fit: Patients with severe complications, such as uncontrolled infections or certain medical conditions like claustrophobia or organ dysfunction, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of aGVHD, enhancing survival rates and quality of life for transplant recipients.
How similar studies have performed: While hyperbaric oxygen therapy has shown effectiveness in other conditions, its application for aGVHD is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing allogeneic stem cell transplantation * Patients develop aGVHD * The count of neutrophilia cells over 0.5 \* 109/L, hemoglobin over 60 g/L, platelet over 30 \*109/L * Signed informed consent Exclusion Criteria: * Unsuitable to the study due to severe complication such as uncontrolled severe infection * Claustrophobia * Ear diseases such as otitis media * Eye diseases such as glaucoma * Epilepsy history * Important organ dysfunction * Coagulopathy
Where this trial is running
Jinan, Shandong
- Shandong Provincial Hospital — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Yujie Jiang, Dr.
- Email: yujiejiang05@126.com
- Phone: 86-13370506886
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.