Breast ReconstructionNCT07140198
Hyperbaric Oxygen Therapy to Improve Autologous Fat Graft Intake in Irradiated Breast
A study testing Hyperbaric Oxygen Therapy in people with Breast Reconstruction and Lipofilling, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Reconstruction, Lipofilling, Hyperbaric Oxygen Therapy
- What is being tested?
- Hyperbaric Oxygen Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 29Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Geneva University Hospitals
Geneva, Canton of Geneva, 1206
Dominik André-Lévigne, MD-PhD, +41 (0)22 372 79 97, dlev@hug.ch
Matteo Scampa, MD, +41 (0)79 553 85 42, asmp@hug.ch
About this study
Official title: Prospective Study to Evaluate the Effectiveness of Hyperbaric Oxygen Therapy (HBOT) to Increase the Survival of Autologous Fat Transfer for Breast Reconstruction After Radiotherapy: A Randomized Controlled Phase II Cross-over 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.
Read the detailed description
This is a prospective, monocentric, randomized controlled phase II crossover clinical trial designed to evaluate the efficacy and safety of hyperbaric oxygen therapy (HBOT) in improving fat graft retention following autologous fat transfer (AFT) in breast reconstruction for patients with prior radiotherapy.
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).
- Being tested
- Hyperbaric Oxygen Therapy, Control
- Keywords
- breast reconstruction, Irradiation, hyperbaric oxygen therapy, lipofilling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyProcedure or surgery
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.
ControlOther
Patients in the control group will undergo standard follow-up after the lipofilling without HBOT.
| Study group | Role | What they receive |
|---|---|---|
| Sequence AB | Other | AFT alone (control) followed by AFT + HBOT (intervention) Receives: Procedure: Hyperbaric Oxygen Therapy; Other: Control |
| Sequence BA | Other | AFT + HBOT followed by AFT alone Receives: Procedure: Hyperbaric Oxygen Therapy; Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of fat graft volume retained
Fat graft volume retention in % is assessed by comparing preoperative and six-month postoperative MRI measurements.
Measured: From enrollment until six months after the second lipofilling procedure.
Secondary outcomes (3)
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.
Measured: Participants will be followed from enrollment to six months after the second lipofilling procedure.
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.
Measured: 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.
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.
Measured: Adverse events will be monitored from the initiation of hyperbaric oxygen therapy until six months after the end of the therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Mar 2026
- Primary completionNov 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominik André-Lévigne, University Hospital, Geneva
- Investigators
- Daniel F Kalbermatten, MD, PhD, Study chair, Geneva University Hospitals, Plastic surgery division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140198
- Sponsor's protocol ID
- 2025-D0050
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to protect patient's privacy and data.
Publications
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.
PubMed 26086386Andre-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.
PubMed 27684570Moen 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.
PubMed 23054400Meier 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.
PubMed 36587606De 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.
PubMed 34439876Liang 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.
PubMed 36168069El-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.
PubMed 26750435Pu LL. Mechanisms of Fat Graft Survival. Ann Plast Surg. 2016 Feb;77 Suppl 1:S84-6. doi: 10.1097/SAP.0000000000000730.
PubMed 26808753Herly 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.
PubMed 30245019Shim 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.
PubMed 28175966Gentilucci 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.
PubMed 32598447Batenburg 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.
PubMed 34279734Mink 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.
PubMed 38329746Pandey 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.
PubMed 36100932
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Evaluate the Effectiveness of Hyperbaric Oxygen Therapy (HBOT) to Increase the Survival of Autologous Fat Transfer for Breast Reconstruction After Radiotherapy: A Randomized Controlled Phase II Cross-over Trial
- ClinicalTrials.gov ID
- NCT07140198
- Acronym / sponsor ID
- 2025-D0050
- Keywords
- breast reconstruction, Irradiation, hyperbaric oxygen therapy, lipofilling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, monocentric, randomized controlled phase II crossover clinical trial designed to evaluate the efficacy and safety of hyperbaric oxygen therapy (HBOT) in improving fat graft retention following autologous fat transfer (AFT) in breast reconstruction for patients with prior radiotherapy.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence AB | Other | Procedure: Hyperbaric Oxygen Therapy, Other: ControlAFT alone (control) followed by AFT + HBOT (intervention) |
| Sequence BA | Other | Procedure: Hyperbaric Oxygen Therapy, Other: ControlAFT + HBOT followed by AFT alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (29 listed)
- Pregnancy or breastfeeding
- Unability to provide informed consent
- Previous enrolment into the current investigation
- Anamnestically reported spontaneous pneumothorax
- Status post-thoracotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen TherapyHBOT 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. | Procedure or surgery | Sequence AB, Sequence BA |
| ControlPatients in the control group will undergo standard follow-up after the lipofilling without HBOT. | Other | Sequence AB, Sequence BA |
Primary outcome
Percentage of fat graft volume retained
Time frame: From enrollment until six months after the second lipofilling procedure.
Fat graft volume retention in % is assessed by comparing preoperative and six-month postoperative MRI measurements.
3 secondary outcomes
Absolute retention of fat graft volume
Time frame: Participants will be followed from enrollment to six months after the second lipofilling procedure.
Clinical and radiological complications of lipofilling
Time frame: 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.
Time frame: Adverse events will be monitored from the initiation of hyperbaric oxygen therapy until six months after the end of the therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Background: PubMed 26086386Strong 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.
- Background: PubMed 27684570Andre-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.
- Background: PubMed 23054400Moen 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.
- Background: PubMed 36587606Meier 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.
- Background: PubMed 34439876De 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.
- Background: PubMed 36168069Liang 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.
- Background: PubMed 26750435El-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.
- Background: PubMed 26808753Pu LL. Mechanisms of Fat Graft Survival. Ann Plast Surg. 2016 Feb;77 Suppl 1:S84-6. doi: 10.1097/SAP.0000000000000730.
- Background: PubMed 30245019Herly 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.
- Background: PubMed 28175966Shim 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.
- Background: PubMed 32598447Gentilucci 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.
- Background: PubMed 34279734Batenburg 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.
- Informative brochure from the Hyperbaric Medicine Division of the Geneva University Hospitals (in French)Link provided by the sponsor.
- Official website of the Hyperbaric Medicine Division of the Geneva University Hospitals with an explanatory videoLink provided by the sponsor.
- Individual participant dataSharing planned: No. In order to protect patient's privacy and data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel F Kalbermatten, MD, PhD study chair
Geneva University Hospitals, Plastic surgery division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygen Therapy in people with Breast Reconstruction and Lipofilling, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominik André-Lévigne, MD, PhD (+41 (0)22 372 79 97, dlev@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of fat graft volume retained (time frame: From enrollment until six months after the second lipofilling procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07140198, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.