Stimulation of Sensation and Improvement in Swallowing Using Oral Capsaicin
|ClinicalTrials.gov Identifier: NCT01053286|
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : May 30, 2017
|Condition or disease|
|Dysphagia Gastroesophageal Reflux|
Swallowing problems are encountered frequently in primary practice and in the hospital setting. The list of possible causes is large, ranging from strokes and neurological disease through to complications of cancer treatment, acid reflux, and surgery. Many patients have a reduced ability to feel food and fluid (reduced sensation) within the throat (pharynx) and this leads to inability to manipulate food and fluids in the correct manner. This can produce a variety of swallowing problems such as choking on foods and fluids, regurgitation, aspiration, weight loss, malnutrition and poor quality of life.
Treatment is largely directed at rehabilitation of muscle power and education about safe swallowing techniques or positioning that limits food and fluid entering the airway. A novel approach is to try to improve sensation within the pharynx so that patients can feel substances present and then manipulate them in a more appropriate and safe manner. In this regard capsaicin, a nutritional supplement derived from peppers, has shown a stimulatory effect on sensory nerves and an ability to improve the swallowing reflex (Ebihara et al., 2005). Although studies have shown that capsaicin can improve the swallowing reflex, data regarding improvement in swallowing function is lacking. Using a small dose of capsaicin administered as a lozenge, we hope to stimulate sensation within the pharynx enough to improve physical swallowing measures on a contrast swallow study. This method of application is comfortable, easy and directed to the site of action.
|Study Type :||Observational|
|Actual Enrollment :||19 participants|
|Official Title:||Stimulation of Sensation and Improvement in Swallowing Using Oral Capsaicin|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
- Improvement in sensation and swallowing after using oral capsaicin [ Time Frame: Outcome measure will be determined during the conduction of the dynamic swallow study ]Pt will undergo a standard protocol for conducting dynamic swallow studies with the use of increasing increments of liquid barium, followed by paste consistency and solid consistency barium items, then large volume and continuous drinking of barium. Pictures are taken in both lateral and anteroposterior views. Patients enrolled in the study will undergo the usual protocol but instead of the straw drinking large volume liquid bolus, they will first receive the capsaicin 0.1mg lozenge then after sucking that for 5 minutes will swallow a second 20cc bolus of liquid contrast agent in lateral view. The lozenge is an FDA approved food nutritional supplement and is available in several forms over-the-counter without a prescription. The capsaicin lozenge we will use will be a 0.1mg lozenge. This is a very small concentration of the supplement. We expect this to take no more than 5 minutes to fully dissolve. They will then finish the protocol (AP views) as usual.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053286
|United States, California|
|University of California Davis Medical Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Peter A Belafsky, MD, Ph.D.||University of California, Davis|