跳至主要内容
临床试验/NCT05078073
NCT05078073招募中不适用

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

Shandong Provincial Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年10月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Overall response rate of HBOT as complete response or partial response for the treatment of aGVHD

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

aGVHD-HBOT free

No Intervention

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

aGVHD-HBOT

Experimental

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

干预措施: Hyperbaric oxygen therapy (Device)

结局指标

主要结局

Overall response rate of HBOT as complete response or partial response for the treatment of aGVHD

时间窗: Four years

Complete or partial response rate of HBOT for the treatment of aGVHD will be measured using Bayesian method.

Incidence of aGVHD when HBOT was administrated as prophylaxis measurement at one month after transplant

时间窗: 100 days post transplant

At one month after transplant, HBOT will be administrated every three days (up to 6 times) to recipients without aGVHD evidence, the incidence of aGVHD will be counted.

次要结局

  • Overall survival rate(Four years)
  • Leukemia-free survival rate(Four years)
  • Relapse rate(Four years)
  • Incidence of adverse events of HBOT(Four years)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Wang Xin

Head of Depertment of Hematology

Shandong Provincial Hospital

研究点 (1)

Loading locations...

相似试验