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
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Salivation rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Xerostomia [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01606644

Contacts
Contact: Lone Forner, DDS, PhD +45 3545 8211 lone.forner@rh.regionh.dk

Locations
Denmark
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    lone.forner@rh.regionh.dk   
Contact: Erik C Jansen, MD. DMSc    +45 3545 1257    erik.jansen@h.regionh.dk   
Sponsors and Collaborators
Lone Forner
Danish Cancer Society
Investigators
Principal Investigator: Lone Forner, DDS, PhD Copenhagen University Hospital
  More Information

No publications provided

Responsible Party: Lone Forner, DDS, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01606644     History of Changes
Other Study ID Numbers: HBO Copenhagen study
Study First Received: May 6, 2010
Last Updated: May 25, 2012
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:
radiation sequelae
hyperbaric oxygen

ClinicalTrials.gov processed this record on October 20, 2014