Saliva, Hyperbaric Oxygen Therapy, & Gland Function: A Prospective Study
Withdrawn before enrolling
Conditions studied: Osteoradionecrosis of the Jaw, Xerostomia
In brief
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.
Key facts
- Study ID
- NCT01532479
- Run by
- Loma Linda University
- People needed
- 0
- Starts
- 2015-08-01
- Expected to finish
- 2022-01-01
- Last updated by the study team
- 2017-04-27
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Loma Linda University Health System — Loma Linda, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.