Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06999785

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood test

Biological

a blood test before and after the first oxygen therapy session, as well as after the last session

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

    8-hydroxy-2'-deoxyguanosine (8-OHdG) plasma levels

  2. 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)

    isoprostanes (8-isoprostane) plasma levels

  3. 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)

    Grade difference on the LENT-SOMA scale (Late Effects of Normal Tissues-Subjective, Objective, Management, Analytic)

Study contacts

Contact information is provided by the study sponsor or research team.

Marie Lemerle, Doctor

CONTACT

[email protected]

0241343118 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: OXYBAR

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 31, 2025
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.