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

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Xerostomia	The improvement of xerostomia following HBO therapy will be measured using standard RTOG head and neck cancer questionnaires.	one year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: State University of New York - Upstate Medical University
• Investigators: Principal Investigator: Marvin Heyboer, MD, State University of New York - Upstate Medical University

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): January 19, 2022
• Study Completion (Actual): January 19, 2022

Study Registration Dates

• First Submitted: May 18, 2015
• First Submitted That Met QC Criteria: May 19, 2015
• First Posted (Estimate): May 21, 2015

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 482428 HBO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No