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Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis

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ClinicalTrials.gov Identifier: NCT00989820
Recruitment Status : Terminated (Recruitment problems, patients refused to participate)
First Posted : October 6, 2009
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Radboud University

October 5, 2009
October 6, 2009
May 31, 2017
October 2009
May 1, 2017   (Final data collection date for primary outcome measure)
absence of exposed bone, fistulae or ulceration. [ Time Frame: 12 months after finishing therapy in the arm assigned to ]
Same as current
Complete list of historical versions of study NCT00989820 on ClinicalTrials.gov Archive Site
  • Pain score [ Time Frame: one year after primairy therapy assigned to. ]
  • Clinical and radiological assessment of the treatment response [ Time Frame: one year after initial therapy ]
  • 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 ]
  • Use of pain medication [ Time Frame: one year after initial therapy ]
  • Type of surgical intervention (sequestrectomy, marginal mandibula resection, segment resection) [ Time Frame: one year after initial therapy ]
  • Quality of life [ Time Frame: one year after initial therapy ]
  • Cost effectiveness [ Time Frame: one year after initial therapy ]
Same as current
Not Provided
Not Provided
 
Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis
Efficacy of Adding Hyperbaric Oxygen Therapy to the Treatment of Late Radiation Damage of the Lower Jaw (Osteoradionecrosis).
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.

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

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Osteoradionecrosis
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
  • 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.
    Intervention: Drug: hyperbaric oxygen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
132
May 1, 2018
May 1, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00989820
NL20963.091.08
Yes
Not Provided
Not Provided
Radboud University
Radboud University
Not Provided
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
Radboud University
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP