Clinical trial NCT04470752: Capsaicin for Post-stroke Dysphagia
Official title: Capsaicin for Post-stroke Dysphagia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Dysphagia, Late Effect of Stroke
Keywords: Dysphagia
Stroke
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
Collaborators: name: Cantonal Hospital of Aarau, Switzerland
name: University Hospital, Basel, Switzerland
First posted: 2020-07-14
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Penetration Aspiration Scale (PAS) score
timeFrame: 7 days after randomisation
Secondary outcomes:
measure: Functional Oral Intake Scale (FOIS) score
timeFrame: at day 7 and 30 post admission
measure: days of nasogastric tube feeding
timeFrame: from randomisation until day 30
measure: number of patients with Percutaneous endoscopic gastrostomy (PEG) tube placement
timeFrame: from randomisation until day 30
measure: number of patients with aspiration pneumonia
timeFrame: from randomisation until day 30
measure: Swallowing quality of life questionnaire (Swal-QoL) score
timeFrame: from randomisation until day 30
measure: Latency of the Swallowing reflex
timeFrame: from randomisation until day 30
measure: modified Ranking Scale (mRS) score
timeFrame: from randomisation until day 30
measure: Change of Penetration Aspiration Scale (PAS) and/or Functional Oral Intake Score (FOIS) with supratentorial stroke
timeFrame: after 7 and 30 days post admission
measure: Change of Penetration Aspiration Scale (PAS) and/or Functional Oral Intake with supra-infratentorial stroke
timeFrame: after 7 and 30 days post admission
Other outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (safety and tolerability)
timeFrame: 30 days post admission
Locations:
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
state: Saint Gallen
Study officials:
affiliation: Cantonal Hospital St. Gallen
name: Georg kägi, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: