- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01606644
Hyperbaric Oxygen - a New Treatment Modality in Patients With Radiation Damaged Salivary Gland Tissue
May 25, 2012 updated by: Lone Forner
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lone Forner, DDS, PhD
- Phone Number: +45 3545 8211
- Email: lone.forner@rh.regionh.dk
Study Locations
-
-
-
Copenhagen, Denmark, DK-2100
- Recruiting
- Department of Anaesthesia and Department of Oral and Maxillofacial Surgery, Copenhagen University Hospital
-
Contact:
- Lone Forner, DDS, PhD
- Phone Number: +45 3545 8211
- Email: lone.forner@rh.regionh.dk
-
Contact:
- Erik C Jansen, MD. DMSc
- Phone Number: +45 3545 1257
- Email: erik.jansen@h.regionh.dk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: HBO
30 90-minute hyperbaric oxygen sessions at 2.4 atm.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Salivation rate
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life
Time Frame: 6 months
|
6 months
|
|
Xerostomia
Time Frame: 6 months
|
Xerostomia questionnaire
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (ANTICIPATED)
April 1, 2014
Study Completion (ANTICIPATED)
April 1, 2014
Study Registration Dates
First Submitted
May 6, 2010
First Submitted That Met QC Criteria
May 25, 2012
First Posted (ESTIMATE)
May 28, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
May 28, 2012
Last Update Submitted That Met QC Criteria
May 25, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HBO Copenhagen study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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