Hyperbaric Oxygen Therapy to Improve Autologous Fat Graft Intake in Irradiated Breast
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Geneva
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnancy or breastfeeding
Unability to provide informed consent
Previous enrolment into the current investigation
Anamnestically reported spontaneous pneumothorax
Trial design
Design model
Crossover
Treatments tested in this trial
Hyperbaric Oxygen Therapy
Procedure/SurgeryHBOT will be administered in five sessions (1 on Day 0, 2 on Day 1, 2 on Day 2), beginning immediately after the lipofilling. Each session consists of 100% oxygen inhalation at 2.5 ATA for 90 minutes. Postoperative MRI will be performed six months after each AFT session to assess the volume of retained graft.
Control
Other interventionPatients in the control group will undergo standard follow-up after the lipofilling without HBOT.
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: Sequence ABOther 2 interventions
Group B: Sequence BAOther 2 interventions
Trial outcomes
Primary outcomes
1
Percentage of fat graft volume retained
Fat graft volume retention in % is assessed by comparing preoperative and six-month postoperative MRI measurements.
Time frame
From enrollment until six months after the second lipofilling procedure.Secondary outcomes
1
Absolute retention of fat graft volume
Six months after each lipofilling procedure, an MRI is performed to evaluate the absolute retention of fat graft volume (in mL) by comparing preoperative and postoperative MRI scans.
Time frame
Participants will be followed from enrollment to six months after the second lipofilling procedure.2
Clinical and radiological complications of lipofilling
During follow-up, after each intervention, patients will be assessed for postoperative complications, including infections, hematoma, implant explantation (if applicable), and reoperation. Radiological complications will also be recorded during each MRI, such as the presence of liponecrosis or oil cysts.
Time frame
Outcomes will be assessed from the time of the first lipofilling procedure through six months following the second procedure.3
Number of Participants with hyperbaric oxygen therapy Related Adverse Events.
All adverse events related to hyperbaric oxygen therapy will be recorded to assess its safety in the context of the study. Premature cessation of hyperbaric oxygen therapy, along with the reasons for discontinuation, will be recorded to assess its tolerability.
Time frame
Adverse events will be monitored from the initiation of hyperbaric oxygen therapy until six months after the end of the therapySponsors and contacts
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Source ClinicalTrials.gov