Modafinil to Improve Fatiguability (NCT05333250)
Modafinil to Improve Fatiguability (MODIFY): Modafinil vs. Placebo Vanguard RCT
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (38 items).
Location: The Ottawa Hospital — Ottawa, Ontario
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- The Ottawa Hospital — Ottawa, Ontario
📞 Contact the Study Coordinator
Phone: (613) 562-6262
Email: shkannathas@ohri.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Cancer-related Cognitive Difficulties clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.