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OncoMatch/Clinical Trials/NCT05333250

Modafinil to Improve Fatiguability

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

Phase 1/2RecruitingOttawa Hospital Research InstituteNCT05333250Data as of Jun 2026Location: Canada

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

Treatments studied

Other

Modafinil

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.

Frequently asked questions

Is NCT05333250 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior cytotoxic chemotherapy, blood transfusion disqualifies patients from enrollment.

What disease stage is eligible?

Stage III or IV is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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