Saliva, Hyperbaric Oxygen Therapy, & Gland Function: A Prospective Study

NCT01532479 | Withdrawn

• 1 other identifier: SHTGN-001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if Hyperbaric Oxygen (HBO) therapy improves salivary gland function in previously head-and-neck irradiated patients. The following will be evaluated: salivary a-amylase, IGF-1, Thrombospondin-1, and VEGF-A concentrations, resting and stimulated salivary flow rate and pH, and salivary buffering capacity. Demographic data, past medical/surgical histories, social history and habits, risk factors, medication list, nutritional status, stage and location of tumor treated, dose/duration of radiation, and time elapsed since radiation treatment will be reviewed and recorded. Subjects will complete a quality of life questionnaire, describe (presence/absence) dry mouth symptoms prior to HBO therapy, and provide current A1c level, or submit to a finger stick. The following groups will be evaluated: 1. Head-and-neck irradiated subjects with ORN (indicating HBO therapy) 2. Subjects with other conditions indicating HBO therapy (positive control), and 3. Head-and-neck irradiated subjects without ORN (negative control). Subjects will include 78 males or females, 18 years old and over. In total, participation will last 22 weeks.

Conditions

Osteoradionecrosis of the Jaw; Xerostomia

Keywords

Osteoradionecrosis; Xerostomia

Outcome Measures

Primary Outcomes (1)

• Volume of Stimulated Saliva

  Pre-treatment to post treatment, average duration of 12 weeks

Secondary Outcomes (6)

• Concentrations of Salivary Thrombospondin-1

  Measured weekly, average duration of treatment is 12 weeks

• Concentration of Salivary IGF-1

  Measured weekly, average duration of treatment is 12 weeks

• Concentration of Salivary VEGF-A

  Measured weekly, average duration of treatment is 12 weeks

• Salivary pH

  Measured weekly, average duration of treatment is 12 weeks

• Salivary buffering capacity

  Measured weekly, average duration of treatment is 12 weeks

Study Arms (3)

Treatment Group

Subjects with ORN treated with Hyperbaric Oxygen Therapy

Postive Control Group

Subjects treated with Hyperbaric Oxygen Therapy that have not had head or neck radiation therapy

Negative Control Group

Subjects who have had head and neck radiation that have not had Hyperbaric Oxygen Therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients in the Loma Linda University Healthcare System

You may qualify if:

• Patient age: 18+.
• Patient must give informed consent.
• Treatment Group
• Patient has completed head and neck irradiation treatment.
• Hyperbaric oxygen therapy is indicated and patient has accepted said treatment.
• Patient must be able to complete hyperbaric oxygen course of treatment.
• Positive Control Group
• Hyperbaric oxygen therapy is indicated and patient has accepted said treatment.
• Patient must be able to complete hyperbaric oxygen course of treatment.
• Negative Control Group
• Patient has completed head and neck irradiation treatment.
• Hyperbaric oxygen therapy has not been used.

You may not qualify if:

• Currently using anti-cholinergic agent, eg: Scopolamine patch, Atropine, Ipratropium, Spiriva.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health System

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Xerostomia; Osteoradionecrosis

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Radiation Injuries; Wounds and Injuries

Study Officials

• Takkin Lo, MD, MPH

  Loma Linda University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2012
• First Posted: February 14, 2012
• Study Start: August 1, 2015
• Primary Completion: August 1, 2021
• Study Completion: January 1, 2022
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

US (1)