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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

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

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.

Detailed Summary:

This is a prospective study in a human model examining treatment of patients who have sustained damage to salivary glands following head and neck radiation, subsequent xerostomia, and who are currently indicated for hyperbaric oxygen therapy for treatment of osteoradionecrosis. Salivary flow rates, pH and buffering capacity before and after hyperbaric oxygen treatments will be collected using GC America (Alsip, Illinois) Saliva-Check BUFFER Kit and results will be recorded. The 6 tests take 10 minutes to complete per patient. According to GC America, these tests are simple, demonstrate salivary dysfunction, help identify factors affecting salivary dysfunction, and assist in the diagnosis of xerostomia. Salivary testing and data collection will occur on 8 independent visits over the course of hyperbaric oxygen treatment and during follow-up. Stimulated saliva samples will be used to measure proteins that are involved in salivary gland revascularization and repair. Saliva samples will be stored at less than or equal to -20C for up to 1 year. Measurements of salivary VEGF-A, IGF-1, and Thrombospondin-1 will be quantified using R&D Systems (Minneapolis, MN) ELISA kits and results will be recorded. Salivary Alpha-Amylase will be measured using Rocky Mountain Diagnostics, Inc (Colorado Springs, CO) Alpha-Amylase Saliva kit. Protein analysis will be done on stimulated saliva samples collected at 4 independent visits: first week, fourth week, eighth week, sixteenth week.

The medical, surgical, and health histories of each participant will be reviewed. Each participant will complete the EORTC quality of life core questionnaire (QLQ - C30 v3.0), including head and neck cancer module, at the start and completion of the trial. A blood sample from each participant will be drawn, and analyzed for A1c levels and albumin levels. During the first, fourth, eighth, and sixteenth week, f
Sponsor: Loma Linda University

Current Primary Outcome: Volume of Stimulated Saliva [ Time Frame: Pre-treatment to post treatment, average duration of 12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Concentrations of Salivary Thrombospondin-1 [ Time Frame: Measured weekly, average duration of treatment is 12 weeks ]
    Measurements will occur at baseline and weekly throughout treatment with one post treatment measurement one week after last treatment
  • Concentration of Salivary IGF-1 [ Time Frame: Measured weekly, average duration of treatment is 12 weeks ]
    Measurements will occur at baseline and weekly throughout treatment with one post treatment measurement one week after last treatment
  • Concentration of Salivary VEGF-A [ Time Frame: Measured weekly, average duration of treatment is 12 weeks ]
    Measurements will occur at baseline and weekly throughout treatment with one post treatment measurement one week after last treatment
  • Salivary pH [ Time Frame: Measured weekly, average duration of treatment is 12 weeks ]
    Measurements will occur at baseline and weekly throughout treatment with one post treatment measurement one week after last treatment
  • Salivary buffering capacity [ Time Frame: Measured weekly, average duration of treatment is 12 weeks ]
    Measurements will occur at baseline and weekly throughout treatment with one post treatment measurement one week after last treatment
  • Impact of HBO treatment on quality of life for ORN patients with xerostomia [ Time Frame: Pre to Post Treatment, average duration of treatment is 12 weeks ]


Original Secondary Outcome: Same as current

Information By: Loma Linda University

Dates:
Date Received: February 8, 2012
Date Started: August 2015
Date Completion: January 2022
Last Updated: April 25, 2017
Last Verified: April 2017