Hyperbaric Oxygen Therapy for Treatment of Severe Radiation-Induced Complications

NCT07422168 | Completed

• 1 other identifier: OI-HBOT-RADIATION-2016-300
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Injury; Radiation-Induced Complications; Radiation Necrosis

Keywords

Hyperbaric oxygen therapy; HBOT

Outcome Measures

Primary Outcomes (1)

• Reduction of severe radiation-induced tissue damage

  Clinical Improvement of Radiation-Induced Complications After HBOT

  Up to 3 months after completion of HBOT treatment

Study Arms (1)

Hyperbaric Oxygen Therapy (HBOT)

EXPERIMENTAL

Patients receiving hyperbaric oxygen therapy to treat severe radiation-induced complications and support tissue healing.

Other: Hyperbaric Oxygen Therapy (HBOT)

Interventions

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.

Hyperbaric Oxygen Therapy (HBOT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years)
• History of radiotherapy
• Clinically significant radiation-induced complications requiring hyperbaric oxygen therapy
• Ability to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Radiation Injuries

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 19, 2026
• Study Start: May 19, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)