Actively Recruiting
Modafinil to Improve Fatiguability
Led by Ottawa Hospital Research Institute · Updated on 2026-01-13
40
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
Sponsors
O
Ottawa Hospital Research Institute
Lead Sponsor
T
The Ottawa Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 currently limited evidence-based pharmacologic interventions available. The investigators will conduct a Vanguard Randomized Clinical Trial (RCT) to estimate the effect of modafinil in managing CRF and CRCI, and to test the feasibility of carrying out the study.
CONDITIONS
Official Title
Modafinil to Improve Fatiguability
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older with stage III or IV cancer diagnosis
- Estimated prognosis of 3 months or more
- Eastern Cooperative Oncology Group (ECOG) Score between 0 and 2
- Experiencing cancer-related fatigue with a score of 4 or higher on the Edmonton Symptom Assessment System-revised-constipation/sleep fatigue item
- Ability to understand and communicate in English
- Ability to give first-person informed consent
You will not qualify if you...
- Receiving or received cytotoxic chemotherapy within the last 6 weeks
- Allergy to modafinil or placebo ingredients
- Dose change of prednisone or dexamethasone in past 7 days or planned during study
- Blood transfusion in last 2 weeks
- Hemoglobin below 80 g/L measured within last 4 weeks
- Thyroid stimulating hormone (TSH) above normal range in last 4 weeks
- Severe liver dysfunction (bilirubin >3x normal or liver enzymes >5x normal)
- Known brain metastasis or primary brain tumor
- Diagnosis of dementia
- Major psychiatric illness such as major depression, bipolar disorder, or schizophrenia
- Uncontrolled high blood pressure (over 140/90 mmHg)
- Unstable angina or recent heart attack within 6 months
- Abnormal heart tests including left ventricular hypertrophy, ischemia, or arrhythmia
- Coronary artery disease with symptoms class greater than 1
- Use of high dose SSRIs or tricyclic antidepressants
- Use of any benzodiazepines, amphetamines, or monoamine oxidase inhibitors
- Use of azole antifungal medications
- Use of certain medications including methylphenidate, cyclosporine, propranolol, phenytoin, warfarin, and others
- Inability to swallow oral capsules
- Pregnancy, breastfeeding, or trying to conceive
- Any other condition or therapy that may affect study compliance or suitability
- Participation in another interventional clinical study or use of investigational drugs within 30 days prior to screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Ottawa Hospital
Ottawa, Ontario, Canada
Actively Recruiting
Research Team
S
Shainuka Kannathas, HBSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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