Clinical trial NCT02450305: Hyperbaric Oxygen and Its Effect on Radiation Induced Long Term Side Effects
Official title: Hyperbaric Oxygen and Its Effect on Radiation Induced Long Term Side Effects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of Head and Neck
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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. .

Eligibility 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

Primary outcomes:
measure: Xerostomia
timeFrame: one year
Secondary outcomes:
measure: Taste alteration
timeFrame: one year
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Marvin Heyboer, MD
role: PRINCIPAL_INVESTIGATOR
References: