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 Locations

  • Denmark
      • Copenhagen, Denmark, DK-2100
        • Recruiting
        • Department of Anaesthesia and Department of Oral and Maxillofacial Surgery, Copenhagen University Hospital
        • Contact:
        • Contact:

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.
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.

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

Lone Forner

Collaborators

Danish Cancer Society

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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