Treatment of Radiation-Induced Complications With Hyperbaric Oxygen Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Reduction of severe radiation-induced tissue damage
研究概览
简要总结
This study evaluates the safety and effectiveness of hyperbaric oxygen therapy (HBOT) for the treatment of severe radiation-induced complications in patients previously treated with radiotherapy. Patients with clinically significant late radiation injuries will undergo HBOT sessions in a hyperbaric chamber. The study aims to assess clinical improvement of radiation damage and overall treatment tolerance.
详细描述
Radiotherapy can cause severe late complications such as tissue necrosis, impaired wound healing, radiation cystitis, radiation proctitis, and other chronic radiation-induced injuries. These conditions may significantly reduce quality of life and can be difficult to treat with standard therapies.
Hyperbaric oxygen therapy (HBOT) involves breathing 100% oxygen under increased atmospheric pressure in a hyperbaric chamber. This increases tissue oxygenation, supports angiogenesis, improves wound healing, and may reduce symptoms associated with radiation injury.
This prospective interventional study will include patients with severe radiation-induced complications referred for HBOT at the Institute of Oncology Ljubljana. Participants will undergo a series of HBOT sessions according to institutional protocol. Clinical outcomes will be documented and analyzed to evaluate treatment effectiveness and safety. Data will be collected prospectively and statistically analyzed to assess the degree of symptom improvement and the occurrence of adverse events related to HBOT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years)
- •History of radiotherapy
- •Clinically significant radiation-induced complications requiring hyperbaric oxygen therapy
- •Ability to provide written informed consent
排除标准
- •Contraindications to hyperbaric oxygen therapy (e.g., untreated pneumothorax)
- •Severe comorbidity preventing safe HBOT treatment
- •Inability to tolerate hyperbaric chamber sessions
- •Withdrawal of informed consent
研究组 & 干预措施
Hyperbaric Oxygen Therapy (HBOT)
Patients receiving hyperbaric oxygen therapy to treat severe radiation-induced complications and support tissue healing.
干预措施: Hyperbaric Oxygen Therapy (HBOT) (Other)
结局指标
主要结局
Reduction of severe radiation-induced tissue damage
时间窗: Up to 3 months after completion of HBOT treatment
Clinical Improvement of Radiation-Induced Complications After HBOT
次要结局
未报告次要终点