Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
CHU Angers
Angers, France
Actively Recruiting
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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