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Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis

Sponsor
Radboud University Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT00989820
Collaborator
(none)
20
Enrollment
8
Locations
2
Arms
103
Anticipated Duration (Months)
2.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: hyperbaric oxygen
 Phase 2/Phase 3

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

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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).
Actual Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
May 1, 2017
Anticipated Study Completion Date :
May 1, 2018

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. absence of exposed bone, fistulae or ulceration. [12 months after finishing therapy in the arm assigned to]

    Secondary Outcome Measures

    1. Pain score [one year after primairy therapy assigned to.]

    2. Clinical and radiological assessment of the treatment response [one year after initial therapy]

    3. 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 initial therapy]

    4. Use of pain medication [one year after initial therapy]

    5. Type of surgical intervention (sequestrectomy, marginal mandibula resection, segment resection) [one year after initial therapy]

    6. Quality of life [one year after initial therapy]

    7. Cost effectiveness [one year after initial therapy]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 NKI/AvL Amsterdam Netherlands 1066CX
    2 VU University Medical centre Amsterdam Netherlands
    3 University Medical Center Groningen Groningen Netherlands
    4 Leiden University Medical Center Leiden Netherlands 2333ZA
    5 Maastricht Universitary Medical Centre Maastricht Netherlands 6229HX
    6 Radboud University Nijmegen Medical Centre Nijmegen Netherlands 6525GA
    7 Erasmus University Medical Center Rotterdam Netherlands 3015CE
    8 University Medical Center Utrecht Utrecht Netherlands 3584CX

    Sponsors and Collaborators

    • Radboud University Medical Center

    Investigators

    • Principal Investigator: Francois Dieleman, MD DMD, Radboud University Medical Center
    • Study Director: Thijs Merkx, MD DMD PhD, Radboud University Medical Center
    • Study Director: Hans Kaanders, MD PhD, Raboud University Medical Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Radboud University Medical Center
    ClinicalTrials.gov Identifier:
    NCT00989820
    Other Study ID Numbers:
    • NL20963.091.08
    First Posted:
    Oct 6, 2009
    Last Update Posted:
    May 31, 2017
    Last Verified:
    Apr 1, 2016
    Keywords provided by Radboud University Medical Center
    osteoradionecrosis
    mandible
    radiotherapy
    hyperbaric oxygen therapy
    Additional relevant MeSH terms:
    Osteoradionecrosis
    Coal Tar

    Study Results

    No Results Posted as of May 31, 2017