CHU Angers
Angers, France
Location status: Recruiting
NCT Number: NCT06999785
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Angers, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Radiation cystitis Radiation proctitis / enteritis Radiation dermatitis Mandibular osteoradionecrosis Or for another indication, without any underlying neoplastic disease
Exclusion criteria
a blood test before and after the first oxygen therapy session, as well as after the last session
Time frame: Baseline (inclusion, before the first oxygen therapy session), during treatment(just after the first oxygen therapy session) and immediately after treatment (just after the last oxygen therapy session)
Tail DNA Percentage by the Comet Assay (cellular biology technique, single-cell gel electrophoresis)
Time frame: Baseline (inclusion, before the first oxygen therapy session), during treatment(just after the first oxygen therapy session) and immediately after treatment (just after the last oxygen therapy session)
8-hydroxy-2'-deoxyguanosine (8-OHdG) plasma levels
Time frame: Baseline (inclusion, before the first oxygen therapy session), during treatment(just after the first oxygen therapy session) and immediately after treatment (just after the last oxygen therapy session)
isoprostanes (8-isoprostane) plasma levels
Time frame: Baseline (inclusion, before the first oxygen therapy session), during treatment(just after the first oxygen therapy session) and immediately after treatment (just after the last oxygen therapy session)
Grade difference on the LENT-SOMA scale (Late Effects of Normal Tissues-Subjective, Objective, Management, Analytic)
Contact information is provided by the study sponsor or research team.
University Hospital, Angers
Other Gov
Acronym: OXYBAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03325959
Fibromyalgia, Hyperbaric Oxygen
Ẕerifin, Israel
View Trial DetailsNCT07263399
Diving Medicine, Healthy Subjects (HS)
Karlskrona, Blekinge County, Sweden
View Trial DetailsNCT04297358
Brain Diseases, Cardiovascular Diseases
Basel, Switzerland
View Trial DetailsNCT04242095
Malignancy, Neoplasms
Anchorage, Alaska, United States
View Trial Details