Condition category
Signs and Symptoms
Date applied
20/10/2010
Date assigned
25/11/2010
Last edited
25/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pere Clavé

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CAPS-01

Study information

Scientific title

Videofluoroscopic evaluation of the therapeutic effect of Tabasco® sauce in dysphagic patients: An open-label, non-randomised controlled trial

Acronym

Study hypothesis

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

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

Study design

Single centre open label non-randomised controlled trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please contact Dr Pere Clavé [pclave@teleline.es] to request a patient information sheet

Condition

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

Phase

Phase IV

Drug names

Primary outcome measures

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 trial start date

25/09/2008

Overall trial end date

14/07/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

8 healthy volunteers; 33 dysphagic patients with Tabasco treatment; 33 dysphagic patients with thickener treatment

Participant 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

Recruitment start date

25/09/2008

Recruitment end date

14/07/2010

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital de Mataró
Mataró
08304
Spain

Sponsor information

Organisation

Hospital de Mataró (Spain)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Proyecto FIS)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes