Hyperbaric Oxygen Therapy to Help Fat Grafts Take in Irradiated Breast

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, crossover, single-center study enrolling 16 adult women who will receive two autologous fat grafting sessions: one with hyperbaric oxygen therapy (HBOT) and one without. HBOT involves 90 minutes of 100% oxygen at 2.5 atmospheres absolute, given in five sessions after the fat grafting procedure. Each participant serves as her own control, with MRI assessments at six months after each graft to measure fat retention and safety outcomes monitored throughout. The trial aims to determine if HBOT improves graft survival and is tolerable in irradiated breast tissue following lipofilling.

Why it matters

Who can join: the full rules

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 :

* 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.

Where it's running

• Geneva University Hospitals
  Geneva, Canton of Geneva, Switzerland Recruiting

Study contacts

• Study coordinator: Dominik André-Lévigne, MD, PhD
• Email: dlev@hug.ch
• Phone: +41 (0)22 372 79 97

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.