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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00760682
Other study ID # DAHANCA 21
Secondary ID
Status Recruiting
Phase Phase 2
First received September 25, 2008
Last updated May 23, 2012
Start date June 2008
Est. completion date April 2015

Study information

Verified date May 2012
Source Rigshospitalet, Denmark
Contact Lone Forner, DDS; PhD
Phone +45 35 45 82 11
Email lone.forner@rh.regionh.dk
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial 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.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Hyperbaric oxygen
30 preoperative and 10 postoperative HBO sessions 90 minutes each. Sequestrectomy is performed after 30 sessions.

Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus
Denmark Department of Anaesthesia, Copenhagen University Hospital Copenhagen
Sweden Sahlgrenska Universitet Gothenburg
United Kingdom Aintree University Hospital Liverpool

Sponsors (1)

Lead Sponsor Collaborator
Lone Forner

Countries where clinical trial is conducted

Denmark,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Osteoradionecrosis status according to the National Cancer Institute Common Toxicity Criteria v 3.0 1 year No
Secondary Life Quality EORTC QoL-30 and H&N35 1 year No
Secondary Body mass index Body mass index 1 year No
Secondary Pain intensity Pain intensity on a VAS scale and based on analgetics consumption 1 year No
Secondary Trismus Ability to open the mouth 1 year No
Secondary Xerostomia Questionnaire 1 year No
Secondary Dysphagia Dysphagia according to the National Cancer Institute Common Toxicity Criteria v 3.0 1 year No
See also
  Status Clinical Trial Phase
Recruiting NCT04265430 - Serial Magnetic Resonance Imaging for the Prediction of Radiation-Induced Changes in Normal Tissue of Patients With Oral Cavity or Skull Base Tumors Phase 4
Terminated NCT00989820 - Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis Phase 2/Phase 3
Completed NCT01147315 - ORN Study: Curative Treatment of Osteoradionecrosis (ORN) With Hybrid Bone Substitution N/A
Not yet recruiting NCT06055257 - Combination Therapy: Hyperbaric Oxygen and PENTOCLO for Treatment of Osteoradionecrosis of the Mandible Phase 3
Recruiting NCT04934644 - The Effect of Hyperbaric Oxygen Treatment in Patients With Osteoradionecrosis. N/A
Active, not recruiting NCT04009161 - Osteoradionecrosis Rate in Patients Undergoing Radiotherapy for Head and Neck Cancer Treatment.
Completed NCT06428994 - Risk for Subsequent Osteoradionecrosis in A Transferred Fibula Flap in Head and Neck Cancer Patients Undergoing Segmental Mandibulectomy: a Cohort Study
Recruiting NCT02661139 - Prospective Registry of Prosthodontic Rehabilitation in Oncology Patients Undergoing Jaw Reconstruction
Recruiting NCT05412849 - Radiation Field, Dose and Fractionation Related to Mandibular Complications
Completed NCT02368457 - Management of Mandibular ORN: PENTO as Medical Treatment Phase 4
Active, not recruiting NCT05325970 - Clinical Registry of Long-Term Dental Outcomes in Head and Neck Cancer Patients
Active, not recruiting NCT02057510 - Observational Study of Dental Outcomes in Head and Neck Cancer Patients
Completed NCT04717765 - Photobiomodulation in Oral Lesions Resulting From Anti-neoplastic Prevention N/A

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