Clinical trial NCT05078073: HBOT in the Treatment and Prevention of aGVHD
Official title: Hyperbaric Oxygen Therapy Improve Acute Graft-Versus-Host Disease in Patients Underwent Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperbaric Oxygen Therapy
Acute-graft-versus-host Disease
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2021-10-14
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Overall response rate of HBOT as complete response or partial response for the treatment of aGVHD
timeFrame: Four years
measure: Incidence of aGVHD when HBOT was administrated as prophylaxis measurement at one month after transplant
timeFrame: 100 days post transplant
Secondary outcomes:
measure: Overall survival rate
timeFrame: Four years
measure: Leukemia-free survival rate
timeFrame: Four years
measure: Relapse rate
timeFrame: Four years
measure: Incidence of adverse events of HBOT
timeFrame: Four years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
Study officials:
affiliation: Shandong Provincial Hospital
name: Xiaoming Zhou, Dr.
role: STUDY_CHAIR
References: