Radiation Injury, Radiation-Induced Complications, Radiation Necrosis
Conditions
Keywords
Hyperbaric oxygen therapy, HBOT
Brief summary
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.
Detailed description
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.
Interventions
Participants will undergo hyperbaric oxygen therapy sessions in a hyperbaric chamber, breathing 100% oxygen under increased atmospheric pressure, according to institutional protocol, to treat severe radiation-induced complications and support tissue healing.
Sponsors
Institute of Oncology Ljubljana
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (≥18 years) * History of radiotherapy * Clinically significant radiation-induced complications requiring hyperbaric oxygen therapy * Ability to provide written informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of severe radiation-induced tissue damage | Up to 3 months after completion of HBOT treatment | Clinical Improvement of Radiation-Induced Complications After HBOT |
Countries
Slovenia
Outcome results
None listed