NCT05078073

HBOT in the Treatment and Prevention of aGVHD

Hyperbaric Oxygen Therapy Improve Acute Graft-Versus-Host Disease in Patients Underwent Allogeneic Hematopoietic Stem Cell Transplantation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shandong Provincial Hospital · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative therapeutic strategy for patients with hematopoietic malignancies. However, the therapeutic benefits and wider application of allo-HSCT are limited by acute graft-versus-host disease (aGVHD), the latter remains a major obstacle against long-term survival for this population. New aGVHD prophylactic and therapeutic strategies that are superior in efficacy, safety, cost-effectiveness, and less technically demanding are still in desperate need. Hyperbaric oxygen therapy (HBOT) has been confirmed as an effective and economical therapeutic modality for hemorrhagic cystitis (HC) whether induced by infection or acute graft-versus-host disease (aGVHD) for transplant recipients. However, little is known about its involvement in aGVHD. In this study, the investigators designed a randomized, controlled, and open clinical trial to confirm the safety and efficacy of HBOT on aGVHD in patient underwent allo-HSCT.

Detailed description

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative therapeutic strategy for patients with hematopoietic malignancies. However, the therapeutic benefits and wider application of allo-HSCT are limited by acute graft-versus-host disease (aGVHD), the latter remains a major obstacle against long-term survival for this population. New aGVHD prophylactic and therapeutic strategies that are superior in efficacy, safety, cost-effectiveness, and less technically demanding are still in desperate need. Although a variety of immune and non-immune cells are involved in the development of aGVHD, reactive oxygen species (ROS) has been proved as the primary triggers of the inflammatory response and play a key role in the pathogenesis of aGVHD. Therefore, strategies targeting ROS production are crucial for effectively managing aGVHD. Hyperbaric oxygen therapy (HBOT) is a well-established treatment method, which is used to improve non-healing ulcers secondary to aGVHD and hemorrhagic cystitis (HC) after allo-HSCT whether induced by infection or aGVHD. Even the exact mechanism is not fully understood, HBOT was demonstrated to reduce a series of pro-inflammatory cytokines release and can improve the action of antibiotics. In this study, the investigators plan to initiate a randomized, controlled, and open clinical cohort study confirm the safety and efficacy of HBOT on aGVHD in patient underwent allo-HSCT.

Conditions

• Hyperbaric Oxygen Therapy
• Acute-graft-versus-host Disease

Interventions

Type	Name	Description
DEVICE	Hyperbaric oxygen therapy	Patients with aGVHD treated with HBOT every two days

Timeline

• Start date: 2021-10-10
• Primary completion: 2024-08-10
• Completion: 2025-08-10
• First posted: 2021-10-14
• Last updated: 2021-10-14

Locations

1 site across 1 country: China