Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
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

Led by University Hospital, Angers · Updated on 2026-04-06

60

Participants Needed

1

Research Sites

122 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults (≥18 years old)
  • Signed informed consent form
  • Affiliated with or beneficiary of a national health insurance system
  • Admitted to the hyperbaric medicine department for HBOT treatment
  • Receiving HBOT for complications related to prior radiotherapy for cancer such as radiation cystitis, radiation proctitis/enteritis, radiation dermatitis, or mandibular osteoradionecrosis, or for another indication without underlying neoplastic disease
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU Angers

Angers, France

Actively Recruiting

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Research Team

M

Marie Lemerle, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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