Status:
NOT_YET_RECRUITING
Hyperbaric Oxygen Therapy to Improve Autologous Fat Graft Intake in Irradiated Breast
Lead Sponsor:
University Hospital, Geneva
Conditions:
Breast Reconstruction
Lipofilling
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn if hyperbaric oxygen therapy (HBOT) enhances fat graft survival in lipofilling procedures in irradiated breast cancer patients. The main questions it aims t...
Detailed Description
This is a prospective, monocentric, randomized controlled phase II crossover clinical trial designed to evaluate the efficacy and safety of hyperbaric oxygen therapy (HBOT) in improving fat graft rete...
Eligibility Criteria
Inclusion
- Adult (18 y.o. or more) female patients considered for lipofilling following breast reconstruction in an oncological setting which received radiation therapy on the affected breast.
- Ability to provide informed consent, documented by signature
Exclusion
- Pregnancy or breastfeeding
- Unability to provide informed consent
- Previous enrolment into the current investigation
- Contra-indication to HBOT :
- Anamnestically reported spontaneous pneumothorax
- Status post-thoracotomy
- Significant intra-pulmonary lesions (including emphysematous bullae)
- Respiratory function disorders (both obstructive and restrictive syndromes)
- Pregnancy
- Major psychiatric disorders
- Uncontrollable claustrophobic reaction
- Seizures, even if treated and asymptomatic for some time
- Status post-severe traumatic brain injury with neurological deficits and seizures
- Decompensated heart failure
- Recent myocardial infarction (\<6 months) or with persistent hemodynamic sequelae
- Spastic coronary angina
- Cardiac arrhythmias, atrioventricular block, Wolff-Parkinson-White syndrome, sinus node dysfunction, Lown-Ganong-Levine syndrome
- Cardiac pacemakers with unknown pressure resistance
- Severe bradycardia
- Sinus ostium displacement (acute or chronic)
- Displacement of the auditory canal entrance (acute or chronic)
- Status post-tympanoplasty type I-III \<3 months
- Acute febrile state
- Optic neuritis
- Unstabilized hyperthyroidism
- Contra-indication to MRI :
- Non-MRI-compatible pacemaker, cochlear implant, drug-infusion pump or neurostimulator.
- Metallic foreign body in critical area (eye, brain, etc.)
- Ferromagnetic vascular surgical clips of older generation, e.g., for intracranial aneurysm repair.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT07140198
Start Date
November 1 2025
End Date
December 1 2028
Last Update
August 24 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.