Do repeated hyperbaric oxygen sessions increase DNA damage after radiotherapy?
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
NA · University Hospital, Angers · NCT06999785
This tests whether repeated hyperbaric oxygen therapy sessions cause more DNA damage in adults who are receiving HBOT after prior radiotherapy or for related complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Angers (other gov) |
| Drugs / interventions | Radiation |
| Locations | 1 site (Angers) |
| Trial ID | NCT06999785 on ClinicalTrials.gov |
What this trial studies
This interventional protocol enrolls adults undergoing hyperbaric oxygen therapy, primarily those treated for complications of prior radiotherapy, and collects blood samples to measure reactive oxygen species and markers of DNA damage. Blood tests are timed around repeated HBOT sessions to characterize short-term increases in ROS and any cumulative changes over multiple exposures. The study compares biomarker levels before and after sessions and over the course of the treatment schedule to see if genotoxic signals are attenuated or amplified with repetition. Results aim to clarify the biological safety profile of repeated HBOT exposures in patients with a history of radiotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults (18+) admitted to the hyperbaric medicine department for HBOT, including those being treated for radiotherapy-related complications and able to give informed consent and use national health insurance.
Not a fit: Patients who are not receiving HBOT, who are pregnant or breastfeeding, legally incapacitated, or deprived of liberty, and those not exposed to prior radiotherapy-related complications are unlikely to gain useful information from this protocol.
Why it matters
Potential benefit: If successful, this could clarify whether repeated HBOT is safe after radiotherapy and guide monitoring or scheduling to reduce long-term mutagenic risk.
How similar studies have performed: Previous work shows a single HBOT session raises ROS and can cause transient DNA damage, but evidence on the effects of repeated sessions is mixed and not conclusive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Angers
- CHU Angers — Angers, France (RECRUITING)
Study contacts
- Study coordinator: Marie Lemerle, Doctor
- Email: marie.lemerle@chu-angers.fr
- Phone: 0241343118
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hyperbaric Oxygen, Genotoxicity, Malignancy