Modafinil to Improve Fatiguability

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Hospital Research Institute
• Collaborators: Bruyere Research Institute; The Ottawa Hospital
• Treatments: Modafinil

Criteria

Inclusion Criteria:

• Stage III or IV cancer diagnosis;

• Has been off cytotoxic chemotherapy for at least 1 month;

• 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 Criteria:

• Allergy to modafinil;

• Has been on stable dose of prednisone and/or dexamethasone for at least 3 days without dosing adjustments;

• Received blood transfusion in the past week;

• Hemoglobin lower than 100g/L for females or 110 g/L for males (measured in past month or at investigator's discretion);

• Thyroid Stimulating Hormone (TSH) above normal range (measured in past month or at investigator's discretion);

• Untreated or symptomatic brain metastasis or primary brain tumours;

• 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.