RecruitingPhase 1Phase 2NCT05333250

Modafinil to Improve Fatiguability

Modafinil to Improve Fatiguability (MODIFY): Modafinil vs. Placebo Vanguard RCT

Sponsor

Ottawa Hospital Research Institute

Enrollment

40 participants

Start Date

Jan 22, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria6

18 years of age or older with stage III or IV cancer diagnosis
Estimated prognosis ≥ 3 months
Eastern Cooperative Oncology Group (ECOG) Score 0-2
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)
Ability to understand and communicate in English
Ability to give first-person informed consent

Exclusion Criteria37

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:
Methylphenidate
Cyclosporine
Propranolol
Phenytoin
S-mephenytoin
Warfarin
Triazolam
Ethinyl estradiol
Clomipramine
Midodrine
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.