Clinical trial NCT01053286: Stimulation of Sensation and Improvement in Swallowing Using Oral Capsaicin
Official title: Stimulation of Sensation and Improvement in Swallowing Using Oral Capsaicin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysphagia
Gastroesophageal Reflux
Keywords: Dysphagia
Globus
Gastroesophageal reflux
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2010-01-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Otolaryngology clinic

Brief summary: This is a research study to learn more about whether capsaicin, a natural ingredient of chili peppers that makes them taste "hot", can improve swallowing function. The purpose of this study is to evaluate whether sucking on a capsaicin lozenge improves sensation in the throat enough to improve swallowing function.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years of age
* Patients with the following condition: dysphagia, globus, gastroesophageal reflux, neurological disease affecting swallowing or any other condition requiring dynamic swallow study
* Patients willing to provide written informed consent for their participation in the study

Exclusion Criteria:

* Patients unable to complete a full dynamic swallow study protocol
* Patients enrolled in another investigational clinical trial that interferes with any testing or testing results
* Patients who are pregnant
* Patients with known sensitivities or allergies to capsaicin or peppers, or nightshades (tomato, bell pepper, eggplant) or latex
* Patients who are prisoners
* Patients who are unable to keep a capsaicin lozenge in their mouth safely for 5 minutes

Primary outcomes:
measure: Improvement in sensation and swallowing after using oral capsaicin
timeFrame: Outcome measure will be determined during the conduction of the dynamic swallow study
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Peter A Belafsky, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: