Hyperbaric Oxygen TherapyNCT05078073
HBOT in the Treatment and Prevention of aGVHD
A study testing Hyperbaric oxygen therapy in people with Hyperbaric Oxygen Therapy and Acute-graft-versus-host Disease, run by Shandong Provincial Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperbaric Oxygen Therapy, Acute-graft-versus-host Disease
- What is being tested?
- Hyperbaric oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2021to 10 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250021
Xiaoming Zhou, Dr.
About this study
Official title: Hyperbaric Oxygen Therapy Improve Acute Graft-Versus-Host Disease in Patients Underwent Allogeneic Hematopoietic Stem Cell Transplantation
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.
Read the 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.
- Being tested
- Hyperbaric oxygen therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen therapyDevice
Patients with aGVHD treated with HBOT every two days
| Study group | Role | What they receive |
|---|---|---|
| aGVHD-HBOT | Experimental | Patients after allo-HSCT will receive hyperbaric oxygen therapy (HBOT) on the next day of the aGVHD diagnosis was determined. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 100 days post transplant
Secondary outcomes (4)
Overall survival rate
Will be summarized by frequency and 95% confidence interval. The distribution of time-to-event endpoints will be estimated by Kaplan-Meier estimate. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test. Cox proportional hazards regression will be employed for multivariate analysis on time-to-event outcomes.
Measured: Four years
Leukemia-free survival rate
Will be summarized by frequency and 95% confidence interval. The distribution of time-to-event endpoints will be estimated by Kaplan-Meier estimate. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test. Cox proportional hazards regression will be employed for multivariate analysis on time-to-event outcomes.
Measured: Four years
Relapse rate
Relapse rate of recipients will be measured using Bayesian method. Will be summarized by frequency and 95% confidence interval.
Measured: Four years
Incidence of adverse events of HBOT
Toxicities will be summarized by grade and by their relationship to treatment.
Measured: Four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start10 Oct 2021 (estimated)
- Primary completion10 Aug 2024 (estimated)
- Study completion10 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperbaric Oxygen TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wang Xin, Shandong Provincial Hospital
- Investigators
- Xiaoming Zhou, Dr., Study chair, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078073
- Sponsor's protocol ID
- HBOT in aGVHD
- Status last verified
- Sep 2021
- First submitted
- 6 Sep 2021
- Last updated
- 14 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy Improve Acute Graft-Versus-Host Disease in Patients Underwent Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05078073
- Acronym / sponsor ID
- HBOT in aGVHD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 10 Oct 2021 (estimated)
- Primary completion
- 10 Aug 2024 (estimated)
- Study completion
- 10 Aug 2025 (estimated)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aGVHD-HBOT | Experimental | Device: Hyperbaric oxygen therapyPatients after allo-HSCT will receive hyperbaric oxygen therapy (HBOT) on the next day of the aGVHD diagnosis was determined. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygen therapyPatients with aGVHD treated with HBOT every two days | Device | aGVHD-HBOT |
Primary outcome
Overall response rate of HBOT as complete response or partial response for the treatment of aGVHD
Time frame: 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
Time frame: 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.
4 secondary outcomes
Overall survival rate
Time frame: Four years
Leukemia-free survival rate
Time frame: Four years
Relapse rate
Time frame: Four years
Incidence of adverse events of HBOT
Time frame: Four years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoming Zhou, Dr. study chair
Shandong Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric oxygen therapy in people with Hyperbaric Oxygen Therapy and Acute-graft-versus-host Disease, run by Shandong Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yujie Jiang, Dr. (86-13370506886, yujiejiang05@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate of HBOT as complete response or partial response for the treatment of aGVHD (time frame: Four years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.