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
Launched by UNIVERSITY HOSPITAL, ANGERS · May 23, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how repeated sessions of Hyperbaric Oxygen Therapy (HBOT) may affect DNA in patients who have undergone treatment for cancer. HBOT involves breathing pure oxygen in a special chamber at higher pressures, which can help with healing from radiation damage and other conditions. While HBOT can be beneficial, it also increases the production of substances called reactive oxygen species (ROS) that can cause DNA damage. The trial aims to understand whether multiple sessions of HBOT could potentially harm patients’ DNA and increase the risk of long-term issues, especially for cancer patients who might already have difficulties with DNA repair.
To participate in this trial, you must be an adult, at least 18 years old, and willing to provide informed consent. You should be receiving HBOT for complications related to previous cancer treatments, such as radiation therapy, or for another medical reason. However, some individuals, including pregnant women and those with certain health conditions, will not be eligible for the study. If you join the trial, you can expect to be monitored for any changes related to DNA damage during and after the therapy sessions. It's important to note that while current information about the safety of HBOT is mostly reassuring, this study will help clarify any potential long-term effects, especially for those with a history of cancer.
Gender
ALL
Eligibility criteria
- 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
About University Hospital, Angers
The University Hospital of Angers is a leading academic medical institution dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital leverages its multidisciplinary expertise and state-of-the-art facilities to investigate new therapeutic approaches and improve patient outcomes. Committed to excellence in patient care and medical education, the University Hospital of Angers collaborates with a network of researchers and healthcare professionals to facilitate groundbreaking studies across various medical fields, ensuring rigorous adherence to ethical standards and regulatory compliance. Through its clinical trial initiatives, the institution aims to contribute significantly to the advancement of medical knowledge and the development of effective treatments.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Angers, , France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported