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

This study is currently recruiting participants.
Verified May 2012 by Rigshospitalet, Denmark
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
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

Additional relevant MeSH terms:
Radiation Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on April 14, 2014