Hyperbaric Oxygen - a New Treatment Modality in Patients With Radiation Damaged Salivary Gland Tissue

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Rigshospitalet, Denmark.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Danish Cancer Society
Information provided by (Responsible Party):
Lone Forner, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01606644
First received: May 6, 2010
Last updated: May 25, 2012
Last verified: May 2012

May 6, 2010
May 25, 2012
May 2010
April 2014   (final data collection date for primary outcome measure)
Salivation rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01606644 on ClinicalTrials.gov Archive Site
  • Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Xerostomia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Xerostomia questionnaire
Same as current
Not Provided
Not Provided
 
Hyperbaric Oxygen - a New Treatment Modality in Patients With Radiation Damaged Salivary Gland Tissue
Hyperbaric Oxygen - a New Treatment Modality in Patients With Radiation Damaged Salivary Gland Tissue.

Randomized clinical trial regarding the effect of hyperbaric oxygen on late radiation tissue injury to salivary gland tissue.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Late Effect of Radiation
Procedure: Hyperbaric oxygen
Inhalation of 100% oxygen for 90 minutes
  • Experimental: HBO
    30 90-minute hyperbaric oxygen sessions at 2.4 atm.
    Intervention: Procedure: Hyperbaric oxygen
  • No Intervention: No HBO
    No intervention. No hyperbaric oxygen is administered. Otherwise, the patient will follow the examination program.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
April 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Head and neck cancer with planned radiation therapy
  • Age > 18 years

Exclusion Criteria:

  • Surgical treatment of head and neck cancer
  • Salivary gland disease
  • Severe claustrophobia
  • Pregnancy or lactation (fertile women must use safe contraceptives)
  • Uncontrolled hypertension (> 220/110)
  • Epilepsy
  • Lack of ability to equalize inner ear pressure
  • Pneumothorax
  • Thoracic surgery within one month before HBO treatment
  • Abuse of alcohol, drugs or narcotics
  • Exposed titanium surfaces or defect titanium in the oral cavity
  • Previous HBO treatment
Both
18 Years and older
No
Contact: Lone Forner, DDS, PhD +45 3545 8211 lone.forner@rh.regionh.dk
Denmark
 
NCT01606644
HBO Copenhagen study
No
Lone Forner, Rigshospitalet, Denmark
Lone Forner
Danish Cancer Society
Principal Investigator: Lone Forner, DDS, PhD Copenhagen University Hospital
Rigshospitalet, Denmark
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP