NCT07422168

Hyperbaric Oxygen Therapy for Treatment of Severe Radiation-Induced Complications

Treatment of Radiation-Induced Complications With Hyperbaric Oxygen Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Institute of Oncology Ljubljana · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radiation Injury
• Radiation-Induced Complications
• Radiation Necrosis

Interventions

Type	Name	Description
OTHER	Hyperbaric Oxygen Therapy (HBOT)	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.

Timeline

• Start date: 2016-05-19
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: Slovenia