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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01606644
Recruitment Status : Unknown
Verified May 2012 by Lone Forner, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : May 28, 2012
Last Update Posted : May 28, 2012
Danish Cancer Society
Information provided by (Responsible Party):
Lone Forner, Rigshospitalet, Denmark

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

Condition or disease Intervention/treatment Phase
Late Effect of Radiation Procedure: Hyperbaric oxygen Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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.
Study Start Date : May 2010
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
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.

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

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 6 months ]
  2. Xerostomia [ Time Frame: 6 months ]
    Xerostomia questionnaire

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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 identifier (NCT number): NCT01606644

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

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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
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Principal Investigator: Lone Forner, DDS, PhD Copenhagen University Hospital at Herlev
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Responsible Party: Lone Forner, DDS, PhD, Rigshospitalet, Denmark Identifier: NCT01606644    
Other Study ID Numbers: HBO Copenhagen study
First Posted: May 28, 2012    Key Record Dates
Last Update Posted: May 28, 2012
Last Verified: May 2012
Keywords provided by Lone Forner, Rigshospitalet, Denmark:
radiation sequelae
hyperbaric oxygen