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OncoMatch/Clinical Trials/NCT05333250

Modafinil to Improve Fatiguability

Is NCT05333250 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Modafinil for cancer-related cognitive difficulties.

Phase 1/2RecruitingOttawa Hospital Research InstituteNCT05333250Data as of May 2026

Treatment: ModafinilCancer-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.

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Extracted eligibility criteria

Disease stage

Required: Stage III, IV

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: cytotoxic chemotherapy

Currently receiving or have received cytotoxic chemotherapy in the last 6 weeks

Cannot have received: blood transfusion

Blood transfusion in the last 2 weeks

Lab requirements

Blood counts

Hemoglobin lower than 80 g/L measured in the last 4 weeks

Liver function

Severe liver dysfunction (total bilirubin >3x upper limit of normal, or aspartate aminotransferase or alanine aminotransferase >5x upper limit of normal)

Cardiac function

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

Hemoglobin lower than 80 g/L measured 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); 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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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