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NCT06999785: OXYBAR
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
NA trial testing Blood test in Hyperbaric Oxygen in 60 participants. Currently enrolling.
1 September 2027
Quick facts
| Lead sponsor | University Hospital, Angers |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 60 |
| Start date | 8 July 2025 |
| Primary completion | 1 September 2027 |
| Estimated completion | 15 November 2027 |
| Sites | 1 location across France |
Drugs / interventions tested
- Blood test — full drug profile →
Conditions studied
- Hyperbaric Oxygen — all drugs for Hyperbaric Oxygen →
- Genotoxicity — all drugs for Genotoxicity →
- Malignancy — all drugs for Malignancy →
Sponsor
University Hospital, Angers
Who can join
18 and older, any sex, with Hyperbaric Oxygen or Genotoxicity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06999785
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06999785 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Angers
- Last refreshed: 6 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06999785.
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