Clinical Trial: Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Efficacy of Adding Hyperbaric Oxygen Therapy to the Treatment of Late Radiation Damage of the Lower Jaw (Osteoradionecrosis).

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.

Detailed Summary:

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


Sponsor: Radboud University

Current Primary Outcome: absence of exposed bone, fistulae or ulceration. [ Time Frame: 12 months after finishing therapy in the arm assigned to ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Radboud University

Dates:
Date Received: October 5, 2009
Date Started: October 2009
Date Completion: October 2017
Last Updated: May 3, 2016
Last Verified: April 2016