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

Cancer of Head and Neck Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02450305
• Other study ID #: 482428 HBO
• Status: Completed
• Start date: August 2013
• Est. completion date: January 19, 2022

Study information

• Verified date: May 2022
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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. .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 19, 2022
• Est. primary completion date: January 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Head and Neck
• Head and Neck Neoplasms

Locations

Country	Name	City	State
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Xerostomia	The improvement of xerostomia following HBO therapy will be measured using standard RTOG head and neck cancer questionnaires.	one year
Secondary	Taste alteration	The improvement of taste alteration following HBO therapy will be measured using standard RTOG head and neck cancer questionnaires.	one year