CADYS: Capsaicin for Post-stroke Dysphagia

Sponsor

Georg Kägi, MD (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04470752

Collaborator

Cantonal Hospital of Aarau, Switzerland (Other), University Hospital, Basel, Switzerland (Other)

Enrollment

Arms

23.2

Anticipated Duration (Months)

Study Details

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.

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.

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Aug 24, 2021

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Penetration Aspiration Scale (PAS) score [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

Functional Oral Intake Scale (FOIS) score [at day 7 and 30 post admission]
Between group differences (capsaicin / placebo) of Functional Oral Intake Scale (FOIS)
days of nasogastric tube feeding [from randomisation until day 30]
Between group differences (capsaicin / placebo) of days of nasogastric tube feedings
number of patients with Percutaneous endoscopic gastrostomy (PEG) tube placement [from randomisation until day 30]
Between group differences (capsaicin / Placebo) of number of patients with PEG tube placement
number of patients with aspiration pneumonia [from randomisation until day 30]
Between group differences (capsaicin / Placebo) of number of patients with aspiration pneumonia
Swallowing quality of life questionnaire (Swal-QoL) score [from randomisation until day 30]
Between group differences (capsaicin / Placebo) of Swallowing quality of life questionnaire (Swal-QoL)
Latency of the Swallowing reflex [from randomisation until day 30]
Between group differences (capsaicin / Placebo) of Latency of the Swallowing reflex
modified Ranking Scale (mRS) score [from randomisation until day 30]
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 [after 7 and 30 days post admission]
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 [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

Incidence of Treatment-Emergent Adverse Events (safety and tolerability) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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