Hyperbaric Oxygen Therapy to Improve Autologous Fat Graft Intake in Irradiated Breast
NCT ID: NCT07140198
Last Updated: 2025-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
16 participants
INTERVENTIONAL
2025-11-30
2028-12-31
Brief Summary
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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.
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Detailed Description
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AFT is widely used in breast reconstruction but is often less effective in irradiated tissues due to reduced vascularization and oxygenation, which compromises graft survival. HBOT, which involves breathing 100% oxygen at 2.5 atmospheres absolute (ATA), has been shown to promote angiogenesis and tissue oxygenation, potentially improving fat graft integration and reducing complications in irradiated tissues.
The study will enroll 16 adult female patients who have undergone radiotherapy as part of their breast cancer treatment and are scheduled to receive two sessions of AFT. Each participant will be randomized to one of two sequences:
* Sequence AB: AFT alone (control) followed by AFT + HBOT (intervention)
* Sequence BA: AFT + HBOT followed by AFT alone HBOT will be administered in five sessions (1 on Day 0, 2 on Day 1, 2 on Day 2), beginning immediately after the fat grafting procedure. 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.
Primary Objective:
To determine whether HBOT significantly improves fat graft retention in irradiated breast tissue, assessed as the percentage of volume retained (measured by MRI) six months postoperatively.
Secondary Objectives:
* To assess the absolute fat volume retention in milliliters
* To evaluate the safety and tolerability of HBOT in this setting
* To assess the incidence of clinical and radiological complications (e.g., infection, hematoma, oil cysts, liponecrosis) The crossover design minimizes inter-patient variability by allowing each patient to serve as her own control. Randomization occurs immediately after the first AFT session.
The anticipated duration of participation per subject is approximately 12 to 18 months, and the total study duration is estimated at 3 years (from November 2025 to November 2028).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Sequence AB
AFT alone (control) followed by AFT + HBOT (intervention)
Hyperbaric Oxygen Therapy
HBOT 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
Patients in the control group will undergo standard follow-up after the lipofilling without HBOT.
Sequence BA
AFT + HBOT followed by AFT alone
Hyperbaric Oxygen Therapy
HBOT 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
Patients in the control group will undergo standard follow-up after the lipofilling without HBOT.
Interventions
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Hyperbaric Oxygen Therapy
HBOT 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
Patients in the control group will undergo standard follow-up after the lipofilling without HBOT.
Eligibility Criteria
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Inclusion Criteria
* Ability to provide informed consent, documented by signature
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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University Hospital, Geneva
OTHER
Responsible Party
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Dominik André-Lévigne
Doctor
Principal Investigators
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Daniel F Kalbermatten, MD, PhD
Role: STUDY_CHAIR
Geneva University Hospitals, Plastic surgery division
Central Contacts
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References
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Strong AL, Cederna PS, Rubin JP, Coleman SR, Levi B. The Current State of Fat Grafting: A Review of Harvesting, Processing, and Injection Techniques. Plast Reconstr Surg. 2015 Oct;136(4):897-912. doi: 10.1097/PRS.0000000000001590.
Andre-Levigne D, Modarressi A, Pignel R, Bochaton-Piallat ML, Pittet-Cuenod B. Hyperbaric oxygen therapy promotes wound repair in ischemic and hyperglycemic conditions, increasing tissue perfusion and collagen deposition. Wound Repair Regen. 2016 Nov;24(6):954-965. doi: 10.1111/wrr.12480. Epub 2016 Oct 18.
Moen I, Stuhr LE. Hyperbaric oxygen therapy and cancer--a review. Target Oncol. 2012 Dec;7(4):233-42. doi: 10.1007/s11523-012-0233-x. Epub 2012 Oct 2.
Meier EL, Mink van der Molen DR, Lansdorp CA, Batenburg MCT, van der Leij F, Verkooijen HM, Boonstra O, Hummelink S, Ulrich DJO. Hyperbaric oxygen therapy for local late radiation toxicity in breast cancer patients: A systematic review. Breast. 2023 Feb;67:46-54. doi: 10.1016/j.breast.2022.12.009. Epub 2022 Dec 22.
De Wolde SD, Hulskes RH, Weenink RP, Hollmann MW, Van Hulst RA. The Effects of Hyperbaric Oxygenation on Oxidative Stress, Inflammation and Angiogenesis. Biomolecules. 2021 Aug 14;11(8):1210. doi: 10.3390/biom11081210.
Liang J, Sun X, Yi L, Lv J. Effect of Hyperbaric Oxygen Therapy on the Survival Rate of Autologous Fat Transplantation. Aesthetic Plast Surg. 2023 Feb;47(1):423-429. doi: 10.1007/s00266-022-03096-y. Epub 2022 Sep 27.
El-Sabawi B, Carey JN, Hagopian TM, Sbitany H, Patel KM. Radiation and breast reconstruction: Algorithmic approach and evidence-based outcomes. J Surg Oncol. 2016 Jun;113(8):906-12. doi: 10.1002/jso.24143. Epub 2016 Jan 11.
Pu LL. Mechanisms of Fat Graft Survival. Ann Plast Surg. 2016 Feb;77 Suppl 1:S84-6. doi: 10.1097/SAP.0000000000000730.
Herly M, Orholt M, Larsen A, Pipper CB, Bredgaard R, Gramkow CS, Katz AJ, Drzewiecki KT, Vester-Glowinski PV. Efficacy of breast reconstruction with fat grafting: A systematic review and meta-analysis. J Plast Reconstr Aesthet Surg. 2018 Dec;71(12):1740-1750. doi: 10.1016/j.bjps.2018.08.024. Epub 2018 Sep 4.
Shim YH, Zhang RH. Literature Review to Optimize the Autologous Fat Transplantation Procedure and Recent Technologies to Improve Graft Viability and Overall Outcome: A Systematic and Retrospective Analytic Approach. Aesthetic Plast Surg. 2017 Aug;41(4):815-831. doi: 10.1007/s00266-017-0793-3. Epub 2017 Feb 7.
Gentilucci M, Mazzocchi M, Alfano C. Effects of Prophylactic Lipofilling After Radiotherapy Compared to Non-Fat Injected Breasts: A Randomized, Objective Study. Aesthet Surg J. 2020 Sep 14;40(10):NP597-NP607. doi: 10.1093/asj/sjaa182.
Batenburg MCT, Maarse W, van der Leij F, Baas IO, Boonstra O, Lansdorp N, Doeksen A, van den Bongard DHJG, Verkooijen HM. The impact of hyperbaric oxygen therapy on late radiation toxicity and quality of life in breast cancer patients. Breast Cancer Res Treat. 2021 Sep;189(2):425-433. doi: 10.1007/s10549-021-06332-2. Epub 2021 Jul 19.
Mink van der Molen DR, Batenburg MCT, Maarse W, van den Bongard DHJG, Doeksen A, de Lange MY, van der Pol CC, Evers DJ, Lansdorp CA, van der Laan J, van de Ven PM, van der Leij F, Verkooijen HM. Hyperbaric Oxygen Therapy and Late Local Toxic Effects in Patients With Irradiated Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2024 Apr 1;10(4):464-474. doi: 10.1001/jamaoncol.2023.6776.
Pandey K, Teguh DN, van Hulst RA. Effect of hyperbaric oxygen treatment on skin elasticity in irradiated patients. Diving Hyperb Med. 2022 Sep 30;52(3):208-212. doi: 10.28920/dhm52.3.208-212.
Related Links
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Informative brochure from the Hyperbaric Medicine Division of the Geneva University Hospitals (in French)
Official website of the Hyperbaric Medicine Division of the Geneva University Hospitals with an explanatory video
Other Identifiers
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2025-D0050
Identifier Type: -
Identifier Source: org_study_id
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