Capsaicin for Post-stroke Dysphagia (CADYS)

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

Study Overview

• Status: Recruiting
• Conditions: Dysphagia, Late Effect of Stroke
• Intervention / Treatment: Drug: InOrpha Solution; Drug: Capsaicin 1% oral solution

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.

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Georg Kägi, Dr.med.; Phone Number: +41 71 494 3594; Email: georg.kaegi@kssg.ch
• Study Contact Backup: Name: Anna Müller, RN; Phone Number: +41 71 494 2958; Email: anna.mueller2@kssg.ch

Study Locations

• Switzerland
  • Saint Gallen
    • St. Gallen, Saint Gallen, Switzerland, 9007
      • Recruiting
      • Kantonsspital St. Gallen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; InOrpha solution/ml, three times daily with meals for the Treatment period, 7 or 30 days.	Drug: InOrpha Solution; glycerol based suspension vehicle
Experimental: Capsaicin; InOrpha solution plus 1 mcg Capsaicin/ml, three times daily with meals for the Treatment period of 7 or 30 days.	Drug: Capsaicin 1% oral solution; Capsaicin 1.0 micrograms/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Oral Intake Scale (FOIS) score	Between group differences (capsaicin / placebo) of Functional Oral Intake Scale (FOIS)	at day 7 and 30 post admission
days of nasogastric tube feeding	Between group differences (capsaicin / placebo) of days of nasogastric tube feedings	from randomisation until day 30
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
number of patients with aspiration pneumonia	Between group differences (capsaicin / Placebo) of number of patients with aspiration pneumonia	from randomisation until day 30
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
Latency of the Swallowing reflex	Between group differences (capsaicin / Placebo) of Latency of the Swallowing reflex	from randomisation until day 30
modified Ranking Scale (mRS) score	Between group differences (capsaicin / Placebo) of modified Ranking Scale (mRS)	from randomisation until day 30
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Georg Kägi, MD
• Collaborators: University Hospital, Basel, Switzerland; Cantonal Hospital of Aarau, Switzerland
• Investigators: Principal Investigator: Georg kägi, Dr. med., Cantonal Hospital St. Gallen

Publications and helpful links

Helpful Links

• PRESS App

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Dysphagia
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Stroke; Deglutition Disorders; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Dermatologic Agents; Antipruritics; Pharmaceutical Solutions; Capsaicin
• Other Study ID Numbers: BASEC 2020-01362; 08.011 (Other Identifier: CTU Kantonsspital St. Gallen)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to upload the study protocol after trial completion
• IPD Sharing Time Frame: after Trial completion indefinitely
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No