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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Percentage of fat graft volume retained
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Sequence AB
AFT alone (control) followed by AFT + HBOT (intervention)
干预措施: Control (Other)
Sequence BA
AFT + HBOT followed by AFT alone
干预措施: Control (Other)
Sequence AB
AFT alone (control) followed by AFT + HBOT (intervention)
干预措施: Hyperbaric Oxygen Therapy (Procedure)
Sequence BA
AFT + HBOT followed by AFT alone
干预措施: Hyperbaric Oxygen Therapy (Procedure)
结局指标
主要结局
Percentage of fat graft volume retained
时间窗: 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.
次要结局
- 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.)
- 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)
研究者
Dominik André-Lévigne
Doctor
University Hospital, Geneva