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Hyperbaric Oxygen and Its Effect on Radiation Induced Long Term Side Effects

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ClinicalTrials.gov Identifier: NCT02450305
Recruitment Status : Enrolling by invitation
First Posted : May 21, 2015
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Marvin Heyboer, State University of New York - Upstate Medical University

Brief Summary:
The investigators intend to determine if patients that are already undergoing Hyperbaric Oxygen (HBO) therapy one year post treatment with radiation therapy for head and neck cancer, experience improvement in xerostomia and/or taste alteration. The investigators will enroll a similar demographic one year post treatment with radiation therapy that does not receive HBO therapy. This is a quality of life study.

Condition or disease
Cancer of Head and Neck

Detailed Description:

Radiation therapy is a commonly utilized treatment modality for head and neck cancer patients. Xerostomia (i.e. dry mouth) (and taste change) are common and most significant side effects of this treatment. Xerostomia leads to several complications for patients including difficulty in chewing, speaking, swallowing, taste and smell abnormalities, oral infections and inflammation, osteoradionecrosis, dental caries and periodontal disease. These conditions tend to lead to an overall decreased quality of life for patients affected.

A possible modality for the treatment of xerostomia is the use of hyperbaric oxygen (HBO) therapy. HBO is the medical use of oxygen at a level higher than atmospheric pressure. It has been proposed that HBO results in accelerated blood vessel growth and repair in tissue injuries by increasing the oxygen partial pressure gradient (Bennett, 2005). Today, the use of HBO is widely accepted for both the treatment and prevention of radiation induced toxicities such as osteoradionecrosis and soft tissue necrosis.

Here at Upstate University Hospital, the investigators treat approximately 20 patients each year with hyperbaric oxygen for either the prevention or management of radiation induced complications such as osteoradionecrosis and /or soft tissue necrosis. The investigators would like to use this group of patients to evaluate the effect of HBO in the improvement of radiation induced xerostomia (and or taste change). The investigators' data will be collected from patients with the use of periodic quality of life questionnaires at 5 timepoints, as well as data relating to the treatment each patient was given. .


Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Hyperbaric Oxygen and Its Effect on Radiation Induced Long Term Side Effects
Study Start Date : August 2013
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Treated with HBO
QOL questionnaires at 5 time points for those having HBO therapy at least one year post radiation therapy for head and neck cancer, daily x6 weeks
Not treated with HBO
QOL questionnaires for those at least one year post radiation therapy for head and neck cancer at 5 times points.



Primary Outcome Measures :
  1. Xerostomia [ Time Frame: one year ]
    The improvement of xerostomia following HBO therapy will be measured using standard RTOG head and neck cancer questionnaires.


Secondary Outcome Measures :
  1. Taste alteration [ Time Frame: one year ]
    The improvement of taste alteration following HBO therapy will be measured using standard RTOG head and neck cancer questionnaires.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that will be receiving HBO therapy for head and neck cancer related side effects and matched controls not receiving HBO therapy
Criteria

Inclusion Criteria:

  • males and females age > 18 previous radiation therapy to the head and neck region at least one year from end of treatment

Exclusion Criteria:

  • history of parotidectomy history of dementia

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 ClinicalTrials.gov identifier (NCT number): NCT02450305


Locations
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: Marvin Heyboer, MD State University of New York - Upstate Medical University

Responsible Party: Marvin Heyboer, MD, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT02450305     History of Changes
Other Study ID Numbers: 482428 HBO
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms