search
Back to results

Capsaicin for Post-stroke Dysphagia (CADYS)

Primary Purpose

Dysphagia, Late Effect of Stroke

Status
Recruiting
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Capsaicin 1% oral solution
InOrpha Solution
Sponsored by
Georg Kägi, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia, Late Effect of Stroke focused on measuring Dysphagia, Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kantonsspital St. GallenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Capsaicin

Arm Description

InOrpha solution/ml, three times daily with meals for the Treatment period, 7 or 30 days.

InOrpha solution plus 1 mcg Capsaicin/ml, three times daily with meals for the Treatment period of 7 or 30 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Functional Oral Intake Scale (FOIS) score
Between group differences (capsaicin / placebo) of Functional Oral Intake Scale (FOIS)
days of nasogastric tube feeding
Between group differences (capsaicin / placebo) of days of nasogastric tube feedings
number of patients with Percutaneous endoscopic gastrostomy (PEG) tube placement
Between group differences (capsaicin / Placebo) of number of patients with PEG tube placement
number of patients with aspiration pneumonia
Between group differences (capsaicin / Placebo) of number of patients with aspiration pneumonia
Swallowing quality of life questionnaire (Swal-QoL) score
Between group differences (capsaicin / Placebo) of Swallowing quality of life questionnaire (Swal-QoL)
Latency of the Swallowing reflex
Between group differences (capsaicin / Placebo) of Latency of the Swallowing reflex
modified Ranking Scale (mRS) score
Between group differences (capsaicin / Placebo) of modified Ranking Scale (mRS)
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)
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

Full Information

First Posted
June 2, 2020
Last Updated
June 19, 2023
Sponsor
Georg Kägi, MD
Collaborators
Cantonal Hospital of Aarau, Switzerland, University Hospital, Basel, Switzerland
search

1. Study Identification

Unique Protocol Identification Number
NCT04470752
Brief Title
Capsaicin for Post-stroke Dysphagia
Acronym
CADYS
Official Title
Capsaicin for Post-stroke Dysphagia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Georg Kägi, MD
Collaborators
Cantonal Hospital of Aarau, Switzerland, University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia, Late Effect of Stroke
Keywords
Dysphagia, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Both study drug and Placebo have identical packaging (brown glass bottle) and labeling (Capsaicin or Placebo). Both use the same liquid suspension, same colour, and consistency..
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
InOrpha solution/ml, three times daily with meals for the Treatment period, 7 or 30 days.
Arm Title
Capsaicin
Arm Type
Experimental
Arm Description
InOrpha solution plus 1 mcg Capsaicin/ml, three times daily with meals for the Treatment period of 7 or 30 days.
Intervention Type
Drug
Intervention Name(s)
Capsaicin 1% oral solution
Intervention Description
Capsaicin 1.0 micrograms/ml
Intervention Type
Drug
Intervention Name(s)
InOrpha Solution
Intervention Description
glycerol based suspension vehicle
Primary Outcome Measure Information:
Title
Penetration Aspiration Scale (PAS) score
Description
the between-group difference of the Penetration Aspiration Scale (PAS) assessed with functional endoscopic evaluation of swallowing (FEES) 7 days after admission.
Time Frame
7 days after randomisation
Secondary Outcome Measure Information:
Title
Functional Oral Intake Scale (FOIS) score
Description
Between group differences (capsaicin / placebo) of Functional Oral Intake Scale (FOIS)
Time Frame
at day 7 and 30 post admission
Title
days of nasogastric tube feeding
Description
Between group differences (capsaicin / placebo) of days of nasogastric tube feedings
Time Frame
from randomisation until day 30
Title
number of patients with Percutaneous endoscopic gastrostomy (PEG) tube placement
Description
Between group differences (capsaicin / Placebo) of number of patients with PEG tube placement
Time Frame
from randomisation until day 30
Title
number of patients with aspiration pneumonia
Description
Between group differences (capsaicin / Placebo) of number of patients with aspiration pneumonia
Time Frame
from randomisation until day 30
Title
Swallowing quality of life questionnaire (Swal-QoL) score
Description
Between group differences (capsaicin / Placebo) of Swallowing quality of life questionnaire (Swal-QoL)
Time Frame
from randomisation until day 30
Title
Latency of the Swallowing reflex
Description
Between group differences (capsaicin / Placebo) of Latency of the Swallowing reflex
Time Frame
from randomisation until day 30
Title
modified Ranking Scale (mRS) score
Description
Between group differences (capsaicin / Placebo) of modified Ranking Scale (mRS)
Time Frame
from randomisation until day 30
Title
Change of Penetration Aspiration Scale (PAS) and/or Functional Oral Intake Score (FOIS) with supratentorial stroke
Description
admission of patients with and without sensory deficits (only supratentorial strokes)
Time Frame
after 7 and 30 days post admission
Title
Change of Penetration Aspiration Scale (PAS) and/or Functional Oral Intake with supra-infratentorial stroke
Description
of patients with stroke localisation with respect to supra-infratentorial localisation and involvement of sensory/motor swallowing cortex with its connections
Time Frame
after 7 and 30 days post admission
Other Pre-specified Outcome Measures:
Title
Incidence of Treatment-Emergent Adverse Events (safety and tolerability)
Description
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.
Time Frame
30 days post admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georg Kägi, Dr.med.
Phone
+41 71 494 3594
Email
georg.kaegi@kssg.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Müller, RN
Phone
+41 71 494 2958
Email
anna.mueller2@kssg.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg kägi, Dr. med.
Organizational Affiliation
Cantonal Hospital St. Gallen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
State/Province
Saint Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We plan to upload the study protocol after trial completion
IPD Sharing Time Frame
after Trial completion indefinitely
Links:
URL
https://play.google.com/store/apps/details?id=ch.kssg.press&hl=en_US
Description
PRESS App

Learn more about this trial

Capsaicin for Post-stroke Dysphagia

We'll reach out to this number within 24 hrs