Capsaicin for Post-stroke Dysphagia

Dysphagia, Late Effect of Stroke Clinical Trial

— CADYS  

Official title:

Capsaicin for Post-stroke Dysphagia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04470752
• Other study ID #: BASEC 2020-01362
• Secondary ID: 08.011
• Status: Recruiting
• Phase: Phase 2
• Start date: August 24, 2021
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: Cantonal Hospital of St. Gallen
• Contact: Georg Kägi, Dr.med.
• Phone: +41 71 494 3594
• Email: georg.kaegi[@]kssg.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomised, double blind, Phase 2 Trial to evaluate the efficacy of oral Capsaicin in patients with post-stroke dysphagia in the (sub-)acute setting.

Description:

After inclusion and the assessment of the swallowing function (PRESS, PAS, FOIS, FEES) patients will be randomised 1:1 to receive 1mcg Capsaicin or Placebo. Oral treatment will be applied 3 times daily either during meals or during regular swallowing tests/trainings accompanied by a Speech Language Pathologist. After re-assessment of the dysphagia after 7 days, patients with persistent dysphagia and applicable for further treatment will be treated for another 23 days with a final clinical swallowing evaluation after a total of 30 days. A Patient Medication Diary will used during the Duration of the Trial to capture compliance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Acute ischemic Stroke
• Impairment of oral intake with FOIS = 4
• Magnetic Resonance Imaging of the brain or CT scan with the finding of a subacute ischemic stroke
• Informed Consent within 48 hours after admission, following initial swallowing assessment

Exclusion Criteria:

• Diagnosis other than ischemic stroke
• Late patient admission >48 hours after stroke onset
• Impairment of functional oral intake scale = 5
• FEES >72h after admission
• PAS <2
• Pre-existing dysphagia
• Dysphagia due to other cause
• No evidence of stroke on imaging
• Recurrent stroke = at least one stroke in the course of the study apart from the index stroke
• Age <18 years
• Current drug abuse
• Amphetamine or amphetamine-like Medication
• Regular oral treatment with chilli pepper extract
• Allergies or known adverse reactions to the consumption of chilli pepper or capsaicin
• Personality disorder
• Severe dementia or delirium
• Other reasons according to physician/investigator because of which the patient cannot participate in the study (not suitable for treatment or examinations)
• withdrawal of consent by participant at any time of the study

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia, Late Effect of Stroke
• Stroke

Intervention

Drug:
• Capsaicin 1% oral solution
Capsaicin 1.0 micrograms/ml
• InOrpha Solution
glycerol based suspension vehicle

Locations

Country	Name	City	State
Switzerland	Kantonsspital St. Gallen	St. Gallen	Saint Gallen

Sponsors (3)

Lead Sponsor	Collaborator
Georg Kägi, MD	Cantonal Hospital of Aarau, Switzerland, University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Treatment-Emergent Adverse Events (safety and tolerability)	Potential harm will be assessed by comparing between-group differences (verum/placebo) of hypothermia and other (serious) adverse events which are not known yet, but will be collected systemically during this trial.	30 days post admission
Primary	Penetration Aspiration Scale (PAS) score	the between-group difference of the Penetration Aspiration Scale (PAS) assessed with functional endoscopic evaluation of swallowing (FEES) 7 days after admission.	7 days after randomisation
Secondary	Functional Oral Intake Scale (FOIS) score	Between group differences (capsaicin / placebo) of Functional Oral Intake Scale (FOIS)	at day 7 and 30 post admission
Secondary	days of nasogastric tube feeding	Between group differences (capsaicin / placebo) of days of nasogastric tube feedings	from randomisation until day 30
Secondary	number of patients with Percutaneous endoscopic gastrostomy (PEG) tube placement	Between group differences (capsaicin / Placebo) of number of patients with PEG tube placement	from randomisation until day 30
Secondary	number of patients with aspiration pneumonia	Between group differences (capsaicin / Placebo) of number of patients with aspiration pneumonia	from randomisation until day 30
Secondary	Swallowing quality of life questionnaire (Swal-QoL) score	Between group differences (capsaicin / Placebo) of Swallowing quality of life questionnaire (Swal-QoL)	from randomisation until day 30
Secondary	Latency of the Swallowing reflex	Between group differences (capsaicin / Placebo) of Latency of the Swallowing reflex	from randomisation until day 30
Secondary	modified Ranking Scale (mRS) score	Between group differences (capsaicin / Placebo) of modified Ranking Scale (mRS)	from randomisation until day 30
Secondary	Change of Penetration Aspiration Scale (PAS) and/or Functional Oral Intake Score (FOIS) with supratentorial stroke	admission of patients with and without sensory deficits (only supratentorial strokes)	after 7 and 30 days post admission
Secondary	Change of Penetration Aspiration Scale (PAS) and/or Functional Oral Intake with supra-infratentorial stroke	of patients with stroke localisation with respect to supra-infratentorial localisation and involvement of sensory/motor swallowing cortex with its connections	after 7 and 30 days post admission

External Links

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