Hyperbaric Oxygen Therapy to Improve Autologous Fat Graft Intake in Irradiated Breast

NCT07140198 | Not Yet Recruiting DMC

• 1 other identifier: 2025-D0050
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Breast Reconstruction; Lipofilling; Hyperbaric Oxygen Therapy

Keywords

breast reconstruction; Irradiation; hyperbaric oxygen therapy; lipofilling

Outcome Measures

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.

  From enrollment until six months after the second lipofilling procedure.

Secondary Outcomes (3)

• Absolute retention of fat graft volume

  Participants will be followed from enrollment to six months after the second lipofilling procedure.

• Clinical and radiological complications of lipofilling

  Outcomes will be assessed from the time of the first lipofilling procedure through six months following the second procedure.

• Number of Participants with hyperbaric oxygen therapy Related Adverse Events.

  Adverse events will be monitored from the initiation of hyperbaric oxygen therapy until six months after the end of the therapy

Study Arms (2)

Sequence AB

OTHER

AFT alone (control) followed by AFT + HBOT (intervention)

Procedure: Hyperbaric Oxygen Therapy; Other: Control

Sequence BA

OTHER

AFT + HBOT followed by AFT alone

Procedure: Hyperbaric Oxygen Therapy; Other: Control

Interventions

Hyperbaric Oxygen Therapy PROCEDURE

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.

Sequence AB; Sequence BA

Control OTHER

Patients in the control group will undergo standard follow-up after the lipofilling without HBOT.

Sequence AB; Sequence BA

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Related Publications (14)

• 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.

  PMID: 26086386 BACKGROUND

• 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.

  PMID: 27684570 BACKGROUND

• 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.

  PMID: 23054400 BACKGROUND

• 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.

  PMID: 36587606 BACKGROUND

• 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.

  PMID: 34439876 BACKGROUND

• 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.

  PMID: 36168069 BACKGROUND

• 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.

  PMID: 26750435 BACKGROUND

• Pu LL. Mechanisms of Fat Graft Survival. Ann Plast Surg. 2016 Feb;77 Suppl 1:S84-6. doi: 10.1097/SAP.0000000000000730.

  PMID: 26808753 BACKGROUND

• 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.

  PMID: 30245019 BACKGROUND

• 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.

  PMID: 28175966 BACKGROUND

• 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.

  PMID: 32598447 BACKGROUND

• 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.

  PMID: 34279734 BACKGROUND

• 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.

  PMID: 38329746 BACKGROUND

• 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.

  PMID: 36100932 BACKGROUND

Related Links

• 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

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Daniel F Kalbermatten, MD, PhD

  Geneva University Hospitals, Plastic surgery division

  STUDY CHAIR

Central Study Contacts

Dominik André-Lévigne, MD, PhD

CONTACT

+41 (0)22 372 79 97; dlev@hug.ch

Matteo Scampa, MD

CONTACT

+41 (0)79 55 38 542; asmp@hug.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share