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HBOT in the Treatment and Prevention of aGVHD

NCT ID: NCT05078073

Last Updated: 2021-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-10

Study Completion Date

2025-08-10

Brief Summary

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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

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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

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Hyperbaric Oxygen Therapy Acute-graft-versus-host Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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aGVHD-HBOT

Patients after allo-HSCT will receive hyperbaric oxygen therapy (HBOT) on the next day of the aGVHD diagnosis was determined.

Group Type EXPERIMENTAL

Hyperbaric oxygen therapy

Intervention Type DEVICE

Patients with aGVHD treated with HBOT every two days

aGVHD-HBOT free

Patients after allo-HSCT will NOT receive hyperbaric oxygen therapy (HBOT) on the next day of the aGVHD diagnosis was determined.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hyperbaric oxygen therapy

Patients with aGVHD treated with HBOT every two days

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong Provincial Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Wang Xin

Head of Depertment of Hematology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaoming Zhou, Dr.

Role: STUDY_CHAIR

Shandong Provincial Hospital

Locations

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Shandong Provincial Hospital

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yujie Jiang, Dr.

Role: CONTACT

[email protected]
86-13370506886

Facility Contacts

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Xiaoming Zhou, Dr.

Role: primary

Other Identifiers

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HBOT in aGVHD

Identifier Type: -

Identifier Source: org_study_id