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The Effect of Hyperbaric Oxygen Treatment in Patients With Osteoradionecrosis.

NCT04934644 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-06-22

No results posted yet for this study

Summary

Osteoradionecrosis (ORN) is a severe delayed radiation-induced injury that can occur in patients whom have been subjected to radiotherapy for head and neck cancer. Hyperbaric oxygen treatment (HBO) is one treatment option. In Sweden it is used in some locations in combination to standard treatment which includes for example antibiotics, pain medication and surgery. There is still not sufficient evidence that this treatment is effective in this group of patients.

The primary aim of this study will be to evaluate HBO as a treatment for osteoradionecrosis in terms of slowing the progression of the disease, or at the best, cure the disease.

Conditions

  • Osteoradionecrosis

Interventions

PROCEDURE

Hyperbaric oxygen treatment

Hyperbaric oxygen treatment 90 min from start to start of decompression. The chamber is pressurized to 2,4 ATA and the patients will be breathing 100% oxygen. Treatments will be given once daily, five days a week (no treatments on weekends and holidays).

Sponsors & Collaborators

  • Göteborg University

    lead OTHER

Principal Investigators

  • Göran Kjeller, Docent · Department of oral and maxillofacial surgery, Institute of odontology, Sahlgrenska Academy, GU

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-19
Primary Completion
2024-03-19
Completion
2024-03-19

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04934644 on ClinicalTrials.gov