NCT05333250 Modafinil to Improve Fatiguability
| NCT ID | NCT05333250 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Ottawa Hospital Research Institute |
| Condition | Cancer-related Cognitive Difficulties |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-03-16 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2026-03-16 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: 1. 18 years of age or older with stage III or IV cancer diagnosis 2. Estimated prognosis ≥ 3 months 3. Eastern Cooperative Oncology Group (ECOG) Score 0-2 4. Experiencing cancer-related fatigue, defined as a score of 4 or greater on the Fatigue item of the Edmonton Symptom Assessment System-revised-constipation/sleep (ESAS-r-cs) 5. Ability to understand and communicate in English 6. Ability to give first-person informed consent Exclusion Criteria: * Currently receiving or have received cytotoxic chemotherapy in the last 6 weeks * Allergy to modafinil or placebo contents * Dose change of prednisone or dexamethasone in the past 7 days or planned dose change during study period * Blood transfusion in the last 2 weeks * Hemoglobin lower than 80 g/L measured in the last 4 weeks * TSH above normal range in the last 4 weeks * Severe liver dysfunction (total bilirubin \>3x upper limit of normal, or aspartate aminotransferase or alanine aminotransferase \>5x upper limit of normal) * Known brain metastasis or primary brain tumor * Documented dementia diagnosis * Documented major psychiatric illness including major depressive episode, bipolar disorder, schizophrenia * Uncontrolled hypertension as defined by a blood pressure greater than 140/90mmHg * Unstable angina * Recent (\<6 months previous) myocardial infarction * Evidence of left ventricular hypertrophy or ischemia on ECG * Arrythmia (e.g., atrial fibrillation) * Coronary artery disease with Canadian Cardiovascular Society Symptoms Class \>1 * Taking high dose selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants * Taking any benzodiazepine at any dose * Taking any amphetamine at any dose * Taking any monoamine oxidase inhibitor (MAOI) at any dose * Taking any azole anti-fungal medication (e.g., fluconazole, itraconazole, or ketoconazole) * Taking any of the following medications at any dose: 1. Methylphenidate 2. Cyclosporine 3. Propranolol 4. Phenytoin 5. S-mephenytoin 6. Warfarin 7. Triazolam 8. Ethinyl estradiol 9. Clomipramine 10. Midodrine 11. Antipyrine * Inability to ingest oral capsule * Pregnancy or lactation, or trying to conceive * Any other history, condition, therapy, or uncontrolled intercurrent illness which could, in the opinion of the Qualified Medical Investigator, affect compliance with study requirements or which would make the participant unsuitable for this study. * Simultaneous participation in another interventional clinical study (e.g., Phase 1-3 clinical studies) or treatment with any investigational medicinal product within 30 days prior to screening visit that could, in the judgment of the Qualified Medical Investigator, affect the patient's participation in or outcome of this clinical trial.
Contact & Investigator
Edward Fitzgibbon, MD, MSc, CCFP(PC)
PRINCIPAL INVESTIGATOR
The Ottawa Hospital
Frequently Asked Questions
Who can join the NCT05333250 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer-related Cognitive Difficulties. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05333250 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05333250 currently recruiting?
Yes, NCT05333250 is actively recruiting participants. Contact the research team at shkannathas@ohri.ca for enrollment information.
Where is the NCT05333250 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT05333250 clinical trial?
NCT05333250 is sponsored by Ottawa Hospital Research Institute. The principal investigator is Edward Fitzgibbon, MD, MSc, CCFP(PC) at The Ottawa Hospital. The trial plans to enroll 40 participants.
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