Hyperbaric Oxygen Therapy for Treatment of Severe Radiation-Induced Complications

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.

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Key information

Conditions

Radiation Injury Radiation Injuries Radiation Necrosis Radiation-Induced Complications Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperbaric Oxygen Therapy (HBOT)

Other

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.

Primary outcomes

Reduction of severe radiation-induced tissue damage

Time frame: Up to 3 months after completion of HBOT treatment

Clinical Improvement of Radiation-Induced Complications After HBOT

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Registry information

Official study title

Treatment of Radiation-Induced Complications With Hyperbaric Oxygen Therapy

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Feb 19, 2026
Registry last updated: Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed