Hyperbaric Oxygen Therapy to Improve Autologous Fat Graft Intake in Irradiated Breast (NCT07140198) | Clinical Trial Compass
RecruitingNot Applicable
Hyperbaric Oxygen Therapy to Improve Autologous Fat Graft Intake in Irradiated Breast
Switzerland16 participantsStarted 2026-03-01
Plain-language 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 to answer are:
Does it improve fat graft survival ? Evaluate safety and tolerability of HBOT in this setting? Researchers will compare patient receiving HBOT to a control group without HBOT to see if.
Sixteen female patients will undergo two autologous fat grafting sessions: one with HBOT and one without, in a randomized sequence. Patients will undergo three MRI during the study to evaluate the fat retention rate.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 :
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of fat graft volume retained
Timeframe: From enrollment until six months after the second lipofilling procedure.