HBOT in the Treatment and Prevention of aGVHD

NCT05078073 | Unknown

• 1 other identifier: HBOT in aGVHD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

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

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

  Four years

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

  100 days post transplant

Secondary Outcomes (4)

• Overall survival rate

  Four years

• Leukemia-free survival rate

  Four years

• Relapse rate

  Four years

• Incidence of adverse events of HBOT

  Four years

Study Arms (2)

aGVHD-HBOT

EXPERIMENTAL

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

Device: Hyperbaric oxygen therapy

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.

Interventions

Hyperbaric oxygen therapy DEVICE

Patients with aGVHD treated with HBOT every two days

aGVHD-HBOT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong Provincial Hospital: lead

Study Sites (1)

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

RECRUITING

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Xiaoming Zhou, Dr.

  Shandong Provincial Hospital

  STUDY CHAIR

Central Study Contacts

Yujie Jiang, Dr.

CONTACT

86-13370506886; yujiejiang05@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Depertment of Hematology

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: October 14, 2021
• Study Start: October 10, 2021
• Primary Completion: August 10, 2024
• Study Completion: August 10, 2025
• Last Updated: October 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)