Videofluoroscopic evaluation of the therapeutic effect of Tabasco® sauce in dysphagic patients

ISRCTN	ISRCTN31088564
DOI	https://doi.org/10.1186/ISRCTN31088564
Secondary identifying numbers	CAPS-01

Submission date: 20/10/2010
Registration date: 25/11/2010
Last edited: 25/11/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Pere Clavé
Scientific

Hospital de Mataró
Carretera Cirera s/n
Planta -2 porta 64
Mataró
08304
Spain

Study information

Study design	Single centre open label non-randomised controlled trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please contact Dr Pere Clavé [pclave@teleline.es] to request a patient information sheet
Scientific title	Videofluoroscopic evaluation of the therapeutic effect of Tabasco® sauce in dysphagic patients: An open-label, non-randomised controlled trial
Study objectives	Background: Oropharyngeal dysphagia is the difficulty to form or to move the alimentary bolus from the mouth to the oesophagus. It is a highly prevalent symptom in neurological and older patients and causes malnutrition and aspiration pneumonia. There are no pharmacological strategies for dysphagic patients and most are treated by changes in bolus viscosity. Hypothesis: Capsaicin from Tabasco sauce acts on the oropharyngeal transient receptor potential cation channel (TRPV1), increasing sensory input and the release of substance P. These actions may accelerate the oropharyngeal swallow response, improving the swallowing in dysphagic patients.
Ethics approval(s)	The local ethics committee (Comitè Ètic d'Invstigació Clínica de l'Hospital de Mataró, Consorci Sanitari del Maresme) approved on the 24th of September 2008
Health condition(s) or problem(s) studied	Oropharyngeal dysphagia
Intervention	All participants will undergo a clinical study of swallowing by a questionnaire and clinical examination by the volume-viscosity swallow test (V-VST) Dysphagic patients will be randomised to either the experimental or control group. Healthy volunteers will enter the control group. 1. Control group: 1.1. Videofluoroscopic control study during bolus swallow of 5, 10 and 20 mL of control substance, to describe biomechanical abnormalities (videofluoroscopic signs) that lead to the pathophysiology of dysphagia in each patient 2. Experimental group: 2.1. Oropharyngeal sensitization by swallowing nectar bolus of 5 mL supplemented with capsaicin 2.2. Two videofluroscopic studies during bolus intake of 5, 10 and 20 mL of experimental substance 2.3. Determination of the degree of acceptability of the experimental substance and comparison with the control substance by hedonic scale All participants will be monitored for adverse effects by a phone call within 48 hours of the study.
Intervention type	Other
Primary outcome measure	1. Efficacy signs: 1.1. Lip closure 1.2. Capacity to form the bolus 1.3. Tongue propulsion 1.4. Presence of oral and pharyngeal residue 1.5. Impaired upper oesophageal sphincter opening 2. Safety signs: 2.1. Glosopalatal seal 2.2. Laryngeal vestibule closure 2.3. Local cords closure 3. Timing of oropharyngeal swallow response: Timing of opening and closing of 3.1. Glosopalatal junction 3.2. Velopharyngeal junction 3.3. Laryngeal vestibule 3.4. Upper oesophageal sphincter
Secondary outcome measures	1. Hyoid movement: 1.1. Maximal vertical and anterior extension 1.2. General profile 2. Mechanics and kinematics: 2.1. Bolus propulsion force 2.2. Mean and maximal bolus velocity 2.3. Kinetic energy
Overall study start date	25/09/2008
Completion date	14/07/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	8 healthy volunteers; 33 dysphagic patients with Tabasco treatment; 33 dysphagic patients with thickener treatment
Key inclusion criteria	1. Age >18 2. History of swallowing difficulties associated with aging and/or neurological diseases (neurodegenerative or non-progressive neurological diseases) 3. Study explained and written subject information given 4. Informed consent signed
Key exclusion criteria	1. Patients suffering idiosyncratic phenomena or who are allergic to any medication, especially iodinated contrast media 2. Patients suffering major respiratory disease or undergoing any type of surgery in the three months prior to the study 3. Patients with a background of alcohol dependence or other drug dependence 4. Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of the study
Date of first enrolment	25/09/2008
Date of final enrolment	14/07/2010

Locations

Countries of recruitment

Spain

Study participating centre

Hospital de Mataró

Mataró
08304
Spain

Sponsor information

Hospital de Mataró (Spain)
Hospital/treatment centre

c/o Pere Clavé
Carretera Cirera s/n
Planta -2 porta 64
Mataró
08304
Spain

"ROR"	https://ror.org/04cy4z909

Funders

Funder type

University/education

Ministry of Science and Innovation (Ministerio de Ciencia e Inovación) (Spain) - Collegial Scholarship 2009/2010, Official Pharmaceutical College of Barcelona FIS Project (ref: PS09/01012) (Beca Collegial 2009/2010, Collegi Oficial de Farmacèutics de Barcelona

No information available

Proyecto FIS)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan