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

NCT02450305 | Completed

• 1 other identifier: 482428 HBO
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Head and Neck

Outcome Measures

Primary Outcomes (1)

• Xerostomia

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

  one year

Secondary Outcomes (1)

• Taste alteration

  one year

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• males and females age \> 18 previous radiation therapy to the head and neck region at least one year from end of treatment

You may not qualify if:

• history of parotidectomy history of dementia

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Marvin Heyboer, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: May 21, 2015
• Study Start: August 1, 2013
• Primary Completion: January 19, 2022
• Study Completion: January 19, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)