Status:
NOT_YET_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
Lead Sponsor:
University Hospital, Angers
Conditions:
Hyperbaric Oxygen
Genotoxicity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 tiss...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06999785
Start Date
September 1 2025
End Date
November 15 2027
Last Update
May 31 2025
Active Locations (1)
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1
CHU Angers
Angers, France