Clinical Trial: Hyperbaric Oxygen Treatment of Mandibular Osteoradionecrosis. A Randomized Clinical Study

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Hyperbaric Oxygen Treatment of Mandibular Osteoradionecrosis. A Randomized Clinical Study

Brief Summary: There is currently not sufficient evidence that hyperbaric oxygen (HBO) benefits the surgical removal of necrotic bone in osteoradionecrosis patients. This study aims at testing the hypothesis that HBO does improve healing after surgical removal of necrotic bone in irradiated previous head and neck cancer patients compared to not receiving HBO.

Detailed Summary:

  1. Study objective

    The objective of the study is to evaluate the effect of hyperbaric oxygen (HBO) on mandibular osteoradionecrosis as an adjunctive to surgical treatment in patients previously irradiated for head and neck cancer.

    Hypothesis: Osteoradionecrosis lesions heal more frequently when administering HBO as an adjunct to surgery.

  2. Introduction and rationale

    Each year, 300 danish patients are diagnosed with oral cancer. The majority of these cancers are planocellular carcinomas. The established treatments are surgery and radiation therapy. Depending on multiple factors such as total radiation dose, fractionation, localization and use of brachytherapy, mandibular osteradionecrosis occurs in 5-15% of previously head and neck irradiated patients.

    Osteradionecrosis is defined by National Cancer Institute (NCI) as radiation-induced cell death in components of bone (e.g., the marrow fat and mineralized tissue). It represents the final common pathway of several disease entities, which result in impaired blood supply to the bone tissue causing bone necrosis. Often, osteoradionecrosis is clinically expressed in relation to surgery or a similar tissue trauma, but may also arise spontaneously several years after radiation treatment. Oral rehabilitation is difficult in these patients as denture wear is painful. Furthermore, radiation-induced hyposalivation complicates retention of dentures, which are normally retained by a thin saliva film. As denture wear appears difficult, insertion of implants seems obvious in these patients. However, the survival rate of dental impla
    Sponsor: Lone Forner

    Current Primary Outcome: Osteoradionecrosis status according to the National Cancer Institute Common Toxicity Criteria v 3.0 [ Time Frame: 1 year ]

    Original Primary Outcome: CTCAE v 3.0 criteria [ Time Frame: 1 year ]

    Current Secondary Outcome:

    • Life Quality [ Time Frame: 1 year ]
      EORTC QoL-30 and H&N35
    • Body mass index [ Time Frame: 1 year ]
      Body mass index
    • Pain intensity [ Time Frame: 1 year ]
      Pain intensity on a VAS scale and based on analgetics consumption
    • Trismus [ Time Frame: 1 year ]
      Ability to open the mouth
    • Xerostomia [ Time Frame: 1 year ]
      Questionnaire
    • Dysphagia [ Time Frame: 1 year ]
      Dysphagia according to the National Cancer Institute Common Toxicity Criteria v 3.0


    Original Secondary Outcome: Life Quality Body Mass Index Pain intensity Trismus Xerostomia Dysphagia Dental status [ Time Frame: 1 year ]

    Information By: Rigshospitalet, Denmark

    Dates:
    Date Received: September 25, 2008
    Date Started: June 2008
    Date Completion: April 2015
    Last Updated: May 23, 2012
    Last Verified: May 2012