Hyperbaric Oxygen Treatment of Mandibular Osteoradionecrosis. A Randomized Clinical Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Lone Forner, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00760682
First received: September 25, 2008
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Osteoradionecrosis
Procedure: Hyperbaric oxygen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Treatment of Mandibular Osteoradionecrosis. A Randomized Clinical Study

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Osteoradionecrosis status according to the National Cancer Institute Common Toxicity Criteria v 3.0 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Life Quality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    EORTC QoL-30 and H&N35

  • Body mass index [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Body mass index

  • Pain intensity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Pain intensity on a VAS scale and based on analgetics consumption

  • Trismus [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Ability to open the mouth

  • Xerostomia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Questionnaire

  • Dysphagia [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Dysphagia according to the National Cancer Institute Common Toxicity Criteria v 3.0


Estimated Enrollment: 114
Study Start Date: June 2008
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Hyperbaric oxygen
No Intervention: 2
Sequestrectomy without HBO treatment

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Lone Forner, DDS, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00760682     History of Changes
Other Study ID Numbers: DAHANCA 21
Study First Received: September 25, 2008
Last Updated: May 23, 2012
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:
osteoradionecrosis
hyperbaric oxygen
sequestrectomy

Additional relevant MeSH terms:
Osteoradionecrosis
Radiation Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014