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
NCT ID: NCT06999785
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-09-01
2027-11-15
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Radiation-induced complications
The interventions which are specific to the study is a blood test before and after the first oxygen therapy session, as well as after the last session
Blood test
a blood test before and after the first oxygen therapy session, as well as after the last session
Interventions
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Blood test
a blood test before and after the first oxygen therapy session, as well as after the last session
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Angers
OTHER_GOV
Responsible Party
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Locations
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CHU Angers
Angers, , France
Countries
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Central Contacts
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Facility Contacts
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Aurélie Hautefort
Role: primary
Other Identifiers
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2025-A00812-47
Identifier Type: OTHER
Identifier Source: secondary_id
49RC24_0248
Identifier Type: -
Identifier Source: org_study_id