beta
Trial Radar AI
Clinical Trial NCT06999785 (OXYBAR) for Hyperbaric Oxygen, Genotoxicity, Malignancy is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

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 (OXYBAR) 60

Not yet recruiting
Clinical Trial NCT06999785 (OXYBAR) is an interventional study for Hyperbaric Oxygen, Genotoxicity, Malignancy and is currently not yet recruiting. Enrollment is planned to begin on 1 September 2025 and continue until the study accrues 60 participants. Led by University Hospital, Angers, this study is expected to complete by 15 November 2027. The latest data from ClinicalTrials.gov was last updated on 31 May 2025.
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 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 t...

Show More
Official Title

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

Conditions
Hyperbaric OxygenGenotoxicityMalignancy
Other Study IDs
  • OXYBAR
  • 49RC24_0248
  • 2025-A00812-47 (Other Identifier) (ANSM)
NCT ID Number
NCT06999785
Start Date (Actual)
2025-09-01
Last Update Posted
2025-05-31
Completion Date (Estimated)
2027-11-15
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Basic Science
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalRadiation-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
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Correlation between hyperbaric oxygen therapy and DNA damages
Tail DNA Percentage by the Comet Assay (cellular biology technique, single-cell gel electrophoresis)
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)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
reactive oxygen derivatives formation
8-hydroxy-2'-deoxyguanosine (8-OHdG) plasma levels
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)
reactive oxygen derivatives formation
isoprostanes (8-isoprostane) plasma levels
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)
Correlation between DNA damage and post-radic wound healing
Grade difference on the LENT-SOMA scale (Late Effects of Normal Tissues-Subjective, Objective, Management, Analytic)
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)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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
University Hospital, Angers logoUniversity Hospital, Angers
Study Central Contact
Contact: Marie Lemerle, Doctor, 0241343118, [email protected]
1 Study Locations in 1 Countries
CHU Angers, Angers, France
Aurélie Hautefort, Contact, 0241355899, [email protected]