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

Completed

• Conditions: Cancer of Head and Neck

• Registration Number: NCT02450305
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-08
• Study First Submitted: 2015-05-18
• Study First Submitted QC: 2015-05-19
• Study First Posted: 2015-05-21
• Primary Completion: 2022-01-19
• Study Completion: 2022-01-19
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Xerostomia	one year	The improvement of xerostomia following HBO therapy will be measured using standard RTOG head and neck cancer questionnaires.

Secondary Outcome Measures

Name	Time	Method
Taste alteration	one year	The improvement of taste alteration following HBO therapy will be measured using standard RTOG head and neck cancer questionnaires.

Trial Locations

Locations (1)

SUNY Upstate Medical University; 🇺🇸 Syracuse, New York, United States