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
|Condition or disease|
|Cancer of Head and Neck|
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|
|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|
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.
- Xerostomia [ Time Frame: one year ]The improvement of xerostomia following HBO therapy will be measured using standard RTOG head and neck cancer questionnaires.
- 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.
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
|United States, New York|
|SUNY Upstate Medical University|
|Syracuse, New York, United States, 13210|
|Principal Investigator:||Marvin Heyboer, MD||State University of New York - Upstate Medical University|