NCT04934644

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 22, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2024

Completed
Last Updated

June 22, 2021

Status Verified

June 1, 2021

Enrollment Period

5 years

First QC Date

May 17, 2021

Last Update Submit

June 14, 2021

Conditions

Osteoradionecrosis

Keywords

OsteoradionecrosisRadiation injuriesHyperbaric oxygenationHyperbaric oxygen treatment

Outcome Measures

Primary Outcomes (1)

  • SH-index

    Assessment of healing of soft and hard tissue using SH-index S0H0-S1H3, where lower scores are a better outcome and higher scores are worse. The classification is based on clinical examination of the soft tissue (S) and radiographies of the hard tissue (H).

    1-4 years

Secondary Outcomes (9)

  • Change in stage of osteoradionecrosis

    1-4 years

  • Infection

    1-4 years

  • Transcutaneous perfusion measurement

    1-4 years

  • Perceived pain

    1-4 years

  • Mouth opening capacity

    1-4

  • +4 more secondary outcomes

Study Arms (2)

Hyperbaric oxygen treatment

EXPERIMENTAL

30 HBO treatments and standard care. If surgery is needed an additional 10 HBO treatments postoperative.

Procedure: Hyperbaric oxygen treatment

Control

NO INTERVENTION

Standard care. Surgery if needed.

Interventions

Hyperbaric oxygen treatmentPROCEDURE

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).

Hyperbaric oxygen treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Osteoradionecrosis in the head and neck area (Stage 1-2b according to the classification by Schwartz and Kagan)
  • Previous radiation with or without chemotherapy of a histologically verified primary tumor in the head and neck area.
  • Patient free of tumor.
  • Autonomous patient.
  • Age ≥18 years old.
  • WHO performance status 0-3.
  • Ability to understand Swedish speech and writing.
  • Received oral and written information about the study and given consent to participate in writing.

You may not qualify if:

  • Contraindications against HBO.
  • Participation in other ongoing study on osteoradionecrosis.
  • Pregnancy or planned pregnancy.
  • Woman in fertile age without effective contraceptive method.
  • Alcohol or drug abuse.
  • WHO performance status 4.
  • Suspicion of recurrent tumor.
  • Mental health disorder or other condition which makes the patient unable to follow study protocol.
  • Not able to give informed concent.
  • Previous HBO.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of oral and maxillofacial surgery, Institute of odontology, Sahlgrenska Academy, University of Gothenburg

Gothenburg, Göteborg, 413 90, Sweden

RECRUITING

Department of Oral and Maxillofacial Surgery, The University Hospital of Skåne

Lund, Skåne County, 22242, Sweden

NOT YET RECRUITING

MeSH Terms

Conditions

OsteoradionecrosisRadiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Göran Kjeller, Docent

    Department of oral and maxillofacial surgery, Institute of odontology, Sahlgrenska Academy, GU

    STUDY DIRECTOR

Central Study Contacts

Louise Sameby, MD

CONTACT

+46313436713louise.sameby@vgregion.se

Göran Kjeller, Docent

CONTACT

+46104417750goran.kjeller@odontologi.gu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2021

First Posted

June 22, 2021

Study Start

March 19, 2019

Primary Completion

March 19, 2024

Study Completion

March 19, 2024

Last Updated

June 22, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)