Hyperbaric OxygenOXYBARNCT06999785
Assessment of the Impact of Increased Production of Reactive Oxygen Species Produced During Repeated Sessions of Hyperbaric Oxygen Therapy in Patients Undergoing Radiotherapy for Neoplasia, on the Occurrence of DNA Damage
A study testing Blood test in people with Hyperbaric Oxygen and Genotoxicity, run by University Hospital, Angers at 1 site in France.
Trial summary
Hyperbaric Oxygen Therapy (HBOT) is a treatment involving the administration of oxygen at pressures higher than atmospheric pressure, with numerous potential indications such as radiation-induced tissue damage, chronic wounds, and more. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperbaric Oxygen, Genotoxicity, Malignancy
- What is being tested?
- Blood test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2025to 15 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years old)
- Having signed an informed consent form
- Affiliated with or beneficiary of a national health insurance system
- Admitted to the hyperbaric medicine department for HBOT treatment
- Either for a complication related to prior radiotherapy (administered for an underlying neoplastic disease), such as:
- Radiation cystitis Radiation proctitis / enteritis Radiation dermatitis Mandibular osteoradionecrosis Or for another indication, without any underlying neoplastic disease
Who cannot join
- Patients with a contraindication to hyperbaric oxygen therapy (HBOT)
- Pregnant, breastfeeding, or postpartum women
- Patients deprived of liberty by judicial or administrative decision
- Patients undergoing involuntary psychiatric treatment
- Patients under legal guardianship or protective custody
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Angers
Angers
Aurélie Hautefort, 0241355899, aurelie.hautefort@chu-angers.fr
About this study
Hyperbaric Oxygen Therapy (HBOT) is a treatment involving the administration of oxygen at pressures higher than atmospheric pressure, with numerous potential indications such as radiation-induced tissue damage, chronic wounds, and more. HBOT significantly increases the amount of dissolved oxygen in tissues, thereby promoting wound healing.
However, this "hyperoxygenation" may also exert toxic effects, particularly through the production of reactive oxygen species (ROS), which can induce DNA damage and potentially promote mutagenesis, thereby increasing long-term neoplastic risk.
Read more
A single HBOT session is associated with a significant increase in ROS production, which may persist for up to 48 hours post-exposure, and is also linked to DNA damage. DNA repair is typically a rapid process, with the activation of protective mechanisms.
The effects of repeated HBOT sessions remain a matter of debate. Reported outcomes range from attenuation of genotoxicity, to exacerbation of DNA damage, or no effect at all (8). In patients with cancer or comorbidities associated with impaired DNA repair capacity, repeated HBOT could be more detrimental, potentially increasing genotoxic effects and cancer risk. This increased oxygen susceptibility in cancer patients has already been observed in normobaric conditions during abdominal surgery, where hyperoxygenation strategies were associated with increased mortality in this subgroup.
A potential pro-carcinogenic effect of HBOT in cancer patients has also been suggested in some case series, though not confirmed by larger studies.
Current literature on HBOT safety remains generally reassuring; however, the possibility of DNA damage and its potential long-term genotoxic consequences cannot be entirely excluded. This question is of particular importance given that many primary indications for HBOT involve patients with a history of malignancy or active cancer
- Conditions
- Hyperbaric Oxygen, Genotoxicity, Malignancy
- Being tested
- Blood test
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testBiological
a blood test before and after the first oxygen therapy session, as well as after the last session
| Study group | Role | What they receive |
|---|---|---|
| Radiation-induced complications | Experimental | The interventions which are specific to the study is a blood test before and after the first oxygen therapy session, as well as after the last session Receives: Biological: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between hyperbaric oxygen therapy and DNA damages
Tail DNA Percentage by the Comet Assay (cellular biology technique, single-cell gel electrophoresis)
Measured: Baseline (inclusion, before the first oxygen therapy session), during treatment(just after the first oxygen therapy session) and immediately after treatment (just after the last oxygen therapy session)
Secondary outcomes (3)
reactive oxygen derivatives formation
8-hydroxy-2'-deoxyguanosine (8-OHdG) plasma levels
Measured: Baseline (inclusion, before the first oxygen therapy session), during treatment(just after the first oxygen therapy session) and immediately after treatment (just after the last oxygen therapy session)
reactive oxygen derivatives formation
isoprostanes (8-isoprostane) plasma levels
Measured: Baseline (inclusion, before the first oxygen therapy session), during treatment(just after the first oxygen therapy session) and immediately after treatment (just after the last oxygen therapy session)
Correlation between DNA damage and post-radic wound healing
Grade difference on the LENT-SOMA scale (Late Effects of Normal Tissues-Subjective, Objective, Management, Analytic)
Measured: Baseline (inclusion, before the first oxygen therapy session), during treatment(just after the first oxygen therapy session) and immediately after treatment (just after the last oxygen therapy session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start8 Jul 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperbaric OxygenStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999785
- Sponsor's protocol ID
- 49RC24_0248
- Other IDs
- 2025-A00812-47
- Acronym
- OXYBAR
- Status last verified
- Mar 2026
- First submitted
- 5 May 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of Increased Production of Reactive Oxygen Species Produced During Repeated Sessions of Hyperbaric Oxygen Therapy in Patients Undergoing Radiotherapy for Neoplasia, on the Occurrence of DNA Damage
- ClinicalTrials.gov ID
- NCT06999785
- Acronym / sponsor ID
- OXYBAR / 49RC24_0248
- Conditions
- Hyperbaric Oxygen, Genotoxicity, Malignancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 31 May 2025 (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.
Hyperbaric Oxygen Therapy (HBOT) is a treatment involving the administration of oxygen at pressures higher than atmospheric pressure, with numerous potential indications such as radiation-induced tissue damage, chronic wounds, and more. HBOT significantly increases the amount of dissolved oxygen in tissues, thereby promoting wound healing.
However, this "hyperoxygenation" may also exert toxic effects, particularly through the production of reactive oxygen species (ROS), which can induce DNA damage and potentially promote mutagenesis, thereby increasing long-term neoplastic risk.
A single HBOT session is associated with a significant increase in ROS production, which may persist for up to 48 hours post-exposure, and is also linked to DNA damage. DNA repair is typically a rapid process, with the activation of protective mechanisms.
The effects of repeated HBOT sessions remain a matter of debate. Reported outcomes range from attenuation of genotoxicity, to exacerbation of DNA damage, or no effect at all (8). In patients with cancer or comorbidities associated with impaired DNA repair capacity, repeated HBOT could be more detrimental, potentially increasing genotoxic effects and cancer risk. This increased oxygen susceptibility in cancer patients has already been observed in normobaric conditions during abdominal surgery, where hyperoxygenation strategies were associated with increased mortality in this subgroup.
A potential pro-carcinogenic effect of HBOT in cancer patients has also been suggested in some case series, though not confirmed by larger studies.
Current literature on HBOT safety remains generally reassuring; however, the possibility of DNA damage and its potential long-term genotoxic consequences cannot be entirely excluded. This question is of particular importance given that many primary indications for HBOT involve patients with a history of malignancy or active cancer
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation-induced complications | Experimental | Biological: Blood testThe interventions which are specific to the study is a blood test before and after the first oxygen therapy session, as well as after the last session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (≥18 years old)
- Having signed an informed consent form
- Affiliated with or beneficiary of a national health insurance system
- Admitted to the hyperbaric medicine department for HBOT treatment
- Either for a complication related to prior radiotherapy (administered for an underlying neoplastic disease), such as:
Key exclusion criteria (5 listed)
- Patients with a contraindication to hyperbaric oxygen therapy (HBOT)
- Pregnant, breastfeeding, or postpartum women
- Patients deprived of liberty by judicial or administrative decision
- Patients undergoing involuntary psychiatric treatment
- Patients under legal guardianship or protective custody
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 |
|---|---|---|
| Blood testa blood test before and after the first oxygen therapy session, as well as after the last session | Biological | Radiation-induced complications |
Primary outcome
Correlation between hyperbaric oxygen therapy and DNA damages
Time frame: Baseline (inclusion, before the first oxygen therapy session), during treatment(just after the first oxygen therapy session) and immediately after treatment (just after the last oxygen therapy session)
Tail DNA Percentage by the Comet Assay (cellular biology technique, single-cell gel electrophoresis)
3 secondary outcomes
reactive oxygen derivatives formation
Time frame: Baseline (inclusion, before the first oxygen therapy session), during treatment(just after the first oxygen therapy session) and immediately after treatment (just after the last oxygen therapy session)
reactive oxygen derivatives formation
Time frame: Baseline (inclusion, before the first oxygen therapy session), during treatment(just after the first oxygen therapy session) and immediately after treatment (just after the last oxygen therapy session)
Correlation between DNA damage and post-radic wound healing
Time frame: Baseline (inclusion, before the first oxygen therapy session), during treatment(just after the first oxygen therapy session) and immediately after treatment (just after the last oxygen therapy session)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test in people with Hyperbaric Oxygen and Genotoxicity, run by University Hospital, Angers at 1 site in France.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 6 Apr 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Lemerle, Doctor (0241343118 ext. +33, marie.lemerle@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between hyperbaric oxygen therapy and DNA damages (time frame: Baseline (inclusion, before the first oxygen therapy session), during treatment(just after the first oxygen therapy session) and immediately after treatment (just after the last oxygen therapy session)). 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 6 Apr 2026.