Status:
NOT_YET_RECRUITING
Modafinil to Improve Fatiguability
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
The Ottawa Hospital
Bruyère Health Research Institute.
Conditions:
Cancer-related Cognitive Difficulties
Cancer-related Problem/Condition
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Cancer-related fatigue (CRF) and cancer-related cognitive impairment (CRCI) are among the most commonly reported disabling symptoms experienced by patients with advanced cancer. However, there are cur...
Detailed Description
Background: Patients with advanced cancer often experience various disabling symptoms. Cancer-related fatigue (CRF) and cancer-related cognitive impairment (CRCI) are among the most common reported s...
Eligibility Criteria
Inclusion
- Stage III or IV cancer diagnosis;
- Has been off cytotoxic chemotherapy for at least 6 weeks;
- Eastern Cooperative Oncology Group (ECOG) score of 0-2;
- Experiencing CRF, defined as score of 4 or greater on the Fatigue item of the Edmonton Symptom Assessment System-revised (ESAS-r);
- Prognosis of at least 3 months;
- Able to understand and communicate in English and/or French;
- Able to give first-person informed consent.
Exclusion
- Allergy to modafinil;
- Dose change of prednisone or dexamethasone in the past 7 days or planned dose change during study period;
- Received blood transfusion in the past 2 weeks;
- Hemoglobin lower than 80 g/L measured within 2 weeks of enrolment;
- Thyroid Stimulating Hormone (TSH) above normal range (measured within 2 weeks or start date);
- Patients with known brain metastasis or primary brain tumors;
- Documented dementia diagnosis;
- Documented major psychiatric illness including major depressive episode, bipolar disorder, or schizophrenia;
- Uncontrolled hypertension, defined as blood pressure higher than 140/80;
- Inability to ingest oral capsule;
- Pregnant or lactating;
- Severe liver dysfunction, defined as newly developed liver enzyme elevation total bilirubin \>3 upper limits of normal, aspartate aminotransferase or alanine aminotransferase \>5 upper limits of normal.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05333250
Start Date
January 1 2025
End Date
March 1 2026
Last Update
August 12 2024
Active Locations (1)
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1
The Ottawa Hospital
Ottawa, Ontario, Canada