NCT00989820

Brief Summary

The purpose of this study is to determine whether hyperbaric oxygen therapy is effective in the treatment of osteoradionecrosis (late complication of radiation therapy) of the jaw.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_2

Geographic Reach
1 country

8 active sites

Status
terminated

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

October 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2009

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

September 15, 2025

Status Verified

December 1, 2020

Enrollment Period

7.6 years

First QC Date

October 5, 2009

Last Update Submit

September 8, 2025

Conditions

Osteoradionecrosis

Keywords

osteoradionecrosismandibleradiotherapyhyperbaric oxygen therapy

Outcome Measures

Primary Outcomes (1)

  • absence of exposed bone, fistulae or ulceration.

    Number of patients with complete healing

    12 months after finishing therapy in the arm assigned to

Secondary Outcomes (7)

  • Pain score

    one year after therapy in the arm assigned to.

  • Clinical and radiological assessment of the treatment response

    one year after therapy in the arm assigned to.

  • Completion of the therapy in the arm for which patient has been randomized; if someone drops out of this study the reason will be scored.

    one year after therapy in the arm assigned to.

  • Use of pain medication

    one year after therapy in the arm assigned to.

  • Type of surgical intervention

    one year after therapy in the arm assigned to.

  • +2 more secondary outcomes

Study Arms (2)

Surgery

NO INTERVENTION

This is the standard arm. Surgery without hyperbaric oxygen treatment

Hyperbaric oxygen therapy with surgery

EXPERIMENTAL

Intervention arm. Hyperbaric oxygen therapy with surgery.

Drug: hyperbaric oxygen

Interventions

hyperbaric oxygenDRUG

30 session inhalation of 100% oxygen in a pressure chamber under 2.4 ATA for 90 minutes a day before surgery and 10 session hyperbaric oxygen therapy (as mentioned before) after surgery

Also known as: Linde Gas Therapeutics Benelux B.V., RVG 30355, ATC code V03AN012
Hyperbaric oxygen therapy with surgery

Eligibility Criteria

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

You may qualify if:

  • Informed consent
  • Age ≥ 18 jr
  • WHO performance status 0-2
  • Last radiation treatment ≥ 6 month ago radiotherapy with curative intention and \> 55 Gy. The affected part of the jaw must be in the target volume area of the radiotherapy field.
  • Local recurrence must be ruled out
  • Necrosis of the jaw with at least one of the following symptoms for over 3 month present:
  • Bone exposition which measures at least 1 cm
  • Evident bone lesions at radiologic evaluation (panorex) that fits the diagnosis ORN.
  • Non-healing extraction socket

You may not qualify if:

  • Former HBO treatment
  • Contra indication for HBO treatment (pneumothorax)
  • Bisphosphonate treatment in the medical history
  • reirradiation in the medical history
  • Osteosynthesis material in the affected area
  • Distant metastasis
  • Primary or recurrent tumor in the affected area
  • Malignancies elsewhere

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

NKI/AvL

Amsterdam, 1066CX, Netherlands

Location

VU University Medical centre

Amsterdam, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Leiden University Medical Center

Leiden, 2333ZA, Netherlands

Location

Maastricht Universitary Medical Centre

Maastricht, 6229HX, Netherlands

Location

Radboud University Nijmegen Medical Centre

Nijmegen, 6525GA, Netherlands

Location

Erasmus University Medical Center

Rotterdam, 3015CE, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584CX, Netherlands

Location

Related Links

MeSH Terms

Conditions

Osteoradionecrosis

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Radiation InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Francois Dieleman, MD DMD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • Thijs Merkx, MD DMD PhD

    Radboud University Medical Center

    STUDY DIRECTOR

  • Hans Kaanders, MD PhD

    Raboud University Medical Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2009

First Posted

October 6, 2009

Study Start

October 1, 2009

Primary Completion

May 1, 2017

Study Completion

March 1, 2020

Last Updated

September 15, 2025

Record last verified: 2020-12

Locations

NL(8)