Do repeated hyperbaric oxygen sessions increase DNA damage after radiotherapy?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU Angers
  Angers, France Recruiting

Study contacts

• Study coordinator: Marie Lemerle, Doctor
• Email: marie.lemerle@chu-angers.fr
• Phone: 0241343118

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.