NCT01532479|Withdrawn
Saliva, Hyperbaric Oxygen Therapy, & Gland Function: A Prospective Study
SHOTGUN
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SHOTGUN
Sponsor study identifier
observational
0
1 country
1
Study Start
August 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 8, 2012
Actual (reported)February 14, 2012
Actual (reported)August 2015
Date type not reportedThis date has not been verified as actual or estimated.
August 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Volume of Stimulated Saliva
Pre-treatment to post treatment, average duration of 12 weeks
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
Subjects with ORN treated with Hyperbaric Oxygen Therapy
Subjects treated with Hyperbaric Oxygen Therapy that have not had head or neck radiation therapy
Subjects who have had head and neck radiation that have not had Hyperbaric Oxygen Therapy
Patients in the Loma Linda University Healthcare System
Loma Linda University Health System
Loma Linda, California, 92354, United States
Takkin Lo, MD, MPH
Loma Linda University School of Medicine
0 participants (actual enrollment reported by the registry).
First Submitted
February 8, 2012
First Posted
February 14, 2012
Study Start
August 2015
Date type not reportedThis date has not been verified as actual or estimated.
Trial of Parotid Sparing Whole Brain Radiation
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Primary Completion
August 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 27, 2017
Record last verified: 2017-04
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Source: ClinicalTrials.gov.
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