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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Lone Forner, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
Danish Cancer Society
Information provided by (Responsible Party):
Lone Forner, Rigshospitalet, Denmark Identifier:
First received: May 6, 2010
Last updated: May 25, 2012
Last verified: May 2012
Randomized clinical trial regarding the effect of hyperbaric oxygen on late radiation tissue injury to salivary gland tissue.

Condition Intervention Phase
Late Effect of Radiation Procedure: Hyperbaric oxygen Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Hyperbaric Oxygen - a New Treatment Modality in Patients With Radiation Damaged Salivary Gland Tissue.

Resource links provided by NLM:

Further study details as provided by Lone Forner, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Salivation rate [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 6 months ]
  • Xerostomia [ Time Frame: 6 months ]
    Xerostomia questionnaire

Estimated Enrollment: 60
Study Start Date: May 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HBO
30 90-minute hyperbaric oxygen sessions at 2.4 atm.
Procedure: Hyperbaric oxygen
Inhalation of 100% oxygen for 90 minutes
No Intervention: No HBO
No intervention. No hyperbaric oxygen is administered. Otherwise, the patient will follow the examination program.


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

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
  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 identifier: NCT01606644

Contact: Lone Forner, DDS, PhD +45 3545 8211

Department of Anaesthesia and Department of Oral and Maxillofacial Surgery, Copenhagen University Hospital Recruiting
Copenhagen, Denmark, DK-2100
Contact: Lone Forner, DDS, PhD    +45 3545 8211   
Contact: Erik C Jansen, MD. DMSc    +45 3545 1257   
Sponsors and Collaborators
Lone Forner
Danish Cancer Society
Principal Investigator: Lone Forner, DDS, PhD Copenhagen University Hospital
  More Information

Responsible Party: Lone Forner, DDS, PhD, Rigshospitalet, Denmark Identifier: NCT01606644     History of Changes
Other Study ID Numbers: HBO Copenhagen study
Study First Received: May 6, 2010
Last Updated: May 25, 2012

Keywords provided by Lone Forner, Rigshospitalet, Denmark:
radiation sequelae
hyperbaric oxygen processed this record on August 23, 2017