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Capsaicin for Post-stroke Dysphagia (CADYS)

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ClinicalTrials.gov Identifier: NCT04470752
Recruitment Status : Not yet recruiting
First Posted : July 14, 2020
Last Update Posted : December 28, 2020
Sponsor:
Collaborators:
Cantonal Hospital of Aarau, Switzerland
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
Georg Kägi, MD, Cantonal Hospital of St. Gallen

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.

Condition or disease Intervention/treatment Phase
Dysphagia, Late Effect of Stroke Drug: Capsaicin 1% oral solution Drug: InOrpha Solution Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Both study drug and Placebo have identical packaging (brown glass bottle) and labeling (Capsaicin or Placebo). Both use the same liquid suspention, same colour, and consistency..
Primary Purpose: Treatment
Official Title: Capsaicin for Post-stroke Dysphagia
Estimated Study Start Date : February 15, 2021
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

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




Primary Outcome Measures :
  1. Penetration Aspiration Scale (PAS) score [ Time Frame: 7 days after randomisation ]
    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 :
  1. Functional Oral Intake Scale (FOIS) score [ Time Frame: at day 7 and 30 post admission ]
    Between group differences (capsaicin / placebo) of Functional Oral Intake Scale (FOIS)

  2. days of nasogastric tube feeding [ Time Frame: from randomisation until day 30 ]
    Between group differences (capsaicin / placebo) of days of nasogastric tube feedings

  3. number of patients with Percutaneous endoscopic gastrostomy (PEG) tube placement [ Time Frame: from randomisation until day 30 ]
    Between group differences (capsaicin / Placebo) of number of patients with PEG tube placement

  4. number of patients with aspiration pneumonia [ Time Frame: from randomisation until day 30 ]
    Between group differences (capsaicin / Placebo) of number of patients with aspiration pneumonia

  5. Swallowing quality of life questionnaire (Swal-QoL) score [ Time Frame: from randomisation until day 30 ]
    Between group differences (capsaicin / Placebo) of Swallowing quality of life questionnaire (Swal-QoL)

  6. Latency of the Swallowing reflex [ Time Frame: from randomisation until day 30 ]
    Between group differences (capsaicin / Placebo) of Latency of the Swallowing reflex

  7. modified Ranking Scale (mRS) score [ Time Frame: from randomisation until day 30 ]
    Between group differences (capsaicin / Placebo) of modified Ranking Scale (mRS)

  8. Change of Penetration Aspiration Scale (PAS) and/or Functional Oral Intake Score (FOIS) with supratentorial stroke [ Time Frame: after 7 and 30 days post admission ]
    admission of patients with and without sensory deficits (only supratentorial strokes)

  9. Change of Penetration Aspiration Scale (PAS) and/or Functional Oral Intake with supra-infratentorial stroke [ Time Frame: after 7 and 30 days post admission ]
    of patients with stroke localisation with respect to supra-infratentorial localisation and involvement of sensory/motor swallowing cortex with its connections


Other Outcome Measures:
  1. Incidence of Treatment-Emergent Adverse Events (safety and tolerability) [ Time Frame: 30 days post admission ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04470752


Contacts
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Contact: Georg Kägi, Dr.med. +41 71 494 3594 georg.kaegi@kssg.ch
Contact: Anna Müller, RN +41 71 494 2958 anna.mueller2@kssg.ch

Sponsors and Collaborators
Georg Kägi, MD
Cantonal Hospital of Aarau, Switzerland
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Georg kägi, Dr. med. Cantonal Hospital St. Gallen
Additional Information:
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Responsible Party: Georg Kägi, MD, Senior Physician and Head of the Stroke Center, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT04470752    
Other Study ID Numbers: BASEC 2020-01362
08.011 ( Other Identifier: CTU Kantonsspital St. Gallen )
First Posted: July 14, 2020    Key Record Dates
Last Update Posted: December 28, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We plan to upload the study protocol after trial completion
Supporting Materials: Study Protocol
Time Frame: after Trial completion indefinitely

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Georg Kägi, MD, Cantonal Hospital of St. Gallen:
Dysphagia
Stroke
Additional relevant MeSH terms:
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Deglutition Disorders
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Capsaicin
Pharmaceutical Solutions
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs