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Completed

NCT Number: NCT02450305

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

About this study

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. .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Xerostomia

    Time frame: one year

    The improvement of xerostomia following HBO therapy will be measured using standard RTOG head and neck cancer questionnaires.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

State University of New York - Upstate Medical University

Other

Registry information

Important dates

Study start
2013
Primary completion
2022
Study completion
2022
First posted
May 21, 2015
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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