Hyperbaric Oxygen Therapy for Treatment of Severe Radiation-Induced Complications

February 18, 2026 updated by: Institute of Oncology Ljubljana

Treatment of Radiation-Induced Complications With Hyperbaric Oxygen Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Institute of Oncology Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyperbaric Oxygen Therapy (HBOT)
Patients receiving hyperbaric oxygen therapy to treat severe radiation-induced complications and support tissue healing.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 3 months after completion of HBOT treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Oncology Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2016

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

February 18, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OI-HBOT-RADIATION-2016-300 (Other Identifier: Institute of Oncology Ljubljana)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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