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Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT00989820
First received: October 5, 2009
Last updated: May 3, 2016
Last verified: April 2016
  Purpose
The purpose of this study is to determine whether hyperbaric oxygen therapy is effective in the treatment of osteoradionecrosis (late damage after radiotherapy) of the jaw.

Condition Intervention Phase
Osteoradionecrosis
Drug: hyperbaric oxygen
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Adding Hyperbaric Oxygen Therapy to the Treatment of Late Radiation Damage of the Lower Jaw (Osteoradionecrosis).

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • absence of exposed bone, fistulae or ulceration. [ Time Frame: 12 months after finishing therapy in the arm assigned to ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain score [ Time Frame: one year after primairy therapy assigned to. ] [ Designated as safety issue: No ]
  • Clinical and radiological assessment of the treatment response [ Time Frame: one year after initial therapy ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: one year after initial therapy ] [ Designated as safety issue: No ]
  • Use of pain medication [ Time Frame: one year after initial therapy ] [ Designated as safety issue: No ]
  • Type of surgical intervention (sequestrectomy, marginal mandibula resection, segment resection) [ Time Frame: one year after initial therapy ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: one year after initial therapy ] [ Designated as safety issue: No ]
  • Cost effectiveness [ Time Frame: one year after initial therapy ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: October 2009
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Surgery
This is the standard arm. Surgery without hyperbaric oxygen treatment
Experimental: Hyperbaric oxygen therapy with surgery
Intervention arm. Hyperbaric oxygen therapy with surgery.
Drug: hyperbaric oxygen
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
Other Names:
  • Linde Gas Therapeutics Benelux B.V.
  • RVG 30355
  • ATC code V03AN012

Detailed Description:

Late radiation damage to the lower jaw (osteoradionecrosis (ORN)) is often seen in patients treated with radiotherapy for a tumor in the head and neck region. Part of the lower jaw becomes non-vital and has to be treated. ORN proofs to be a condition difficult to treat and the treatment for this condition varies.

In many countries hyperbaric oxygen therapy (HBOT) is added to the surgical treatment of ORN. Unfortunately there is no consensus whether the addition of hyperbaric oxygen therapy to the treatment of ORN is beneficial or not. This study has the aim to investigate the efficacy and cost-effectiveness of HBOT in the treatment of ORN

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989820

Locations
Netherlands
NKI/AvL
Amsterdam, Netherlands, 1066CX
VU University Medical centre
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2333ZA
Maastricht Universitary Medical Centre
Maastricht, Netherlands, 6229HX
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6525GA
Erasmus University Medical Center
Rotterdam, Netherlands, 3015CE
University Medical Center Utrecht
Utrecht, Netherlands, 3584CX
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Francois Dieleman, MD DMD Radboud University
Study Director: Thijs Merkx, MD DMD PhD Radboud University
Study Director: Hans Kaanders, MD PhD Raboud University Medical Centre
  More Information

Additional Information:
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT00989820     History of Changes
Other Study ID Numbers: NL20963.091.08 
Study First Received: October 5, 2009
Last Updated: May 3, 2016
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
osteoradionecrosis
mandible
radiotherapy
hyperbaric oxygen therapy

Additional relevant MeSH terms:
Osteoradionecrosis
Radiation Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on December 02, 2016