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Hyperbaric Oxygen Treatment of Mandibular Osteoradionecrosis. A Randomized Clinical Study

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ClinicalTrials.gov Identifier: NCT00760682
Recruitment Status : Unknown
Verified May 2012 by Lone Forner, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : September 26, 2008
Last Update Posted : May 25, 2012
Sponsor:
Information provided by (Responsible Party):
Lone Forner, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Osteoradionecrosis Procedure: Hyperbaric oxygen Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Treatment of Mandibular Osteoradionecrosis. A Randomized Clinical Study
Study Start Date : June 2008
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: 1
30 preoperative HBO sessions, sequestrectomy and 10 postoperative HBO sessions. The duration of each session is 90 minutes. 100 % oxygen is inhaled during decompression to 2.4 ATA.
Procedure: Hyperbaric oxygen
30 preoperative and 10 postoperative HBO sessions 90 minutes each. Sequestrectomy is performed after 30 sessions.

No Intervention: 2
Sequestrectomy without HBO treatment



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

Secondary Outcome Measures :
  1. Life Quality [ Time Frame: 1 year ]
    EORTC QoL-30 and H&N35

  2. Body mass index [ Time Frame: 1 year ]
    Body mass index

  3. Pain intensity [ Time Frame: 1 year ]
    Pain intensity on a VAS scale and based on analgetics consumption

  4. Trismus [ Time Frame: 1 year ]
    Ability to open the mouth

  5. Xerostomia [ Time Frame: 1 year ]
    Questionnaire

  6. Dysphagia [ Time Frame: 1 year ]
    Dysphagia according to the National Cancer Institute Common Toxicity Criteria v 3.0



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Osteoradionecrosis grade 2, 3 or 4 according to the CTCAE v 3.0 criteria
  • Localized to the mandibula
  • > 18 yrs old

Exclusion Criteria:

  • Existing malignant disease
  • Previous HBO
  • Pregnancy or lactation
  • Uncontrollable claustrophobia
  • Undrained pneumothorax
  • Blood pressure > 220/110
  • Exposed titanium reconstruction device

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00760682


Contacts
Contact: Lone Forner, DDS; PhD +45 35 45 82 11 lone.forner@rh.regionh.dk
Contact: Erik Jansen, MD, DMSc +45 35 45 12 57 erik.jansen@rh.regionh.dk

Locations
Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark
Contact: Per Johan Sixten Blomlöf         
Contact: Malene Helleberg         
Department of Anaesthesia, Copenhagen University Hospital Recruiting
Copenhagen, Denmark, 2100
Contact: Lone Forner, DDS, PhD    +45 35 45 82 11    lone.forner@rh.regionh.dk   
Contact: Erik Jansen, MD, DMSc    +45 35 45 12 57    erik.jansen@rh.regionh.dk   
Principal Investigator: Lone Forner, DDS, PhD         
Sweden
Sahlgrenska Universitet Recruiting
Gothenburg, Sweden
Contact: Per Arnell         
United Kingdom
Aintree University Hospital Not yet recruiting
Liverpool, United Kingdom
Contact: Richard John Shaw         
Sponsors and Collaborators
Lone Forner
Investigators
Principal Investigator: Lone Forner, DDS, PhD Copenhagen University Hospital

Additional Information:
Responsible Party: Lone Forner, DDS, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00760682     History of Changes
Other Study ID Numbers: DAHANCA 21
First Posted: September 26, 2008    Key Record Dates
Last Update Posted: May 25, 2012
Last Verified: May 2012

Keywords provided by Lone Forner, Rigshospitalet, Denmark:
osteoradionecrosis
hyperbaric oxygen
sequestrectomy

Additional relevant MeSH terms:
Osteoradionecrosis
Radiation Injuries
Wounds and Injuries