Could a wakefulness drug beat cancer fatigue? new trial aims to find out.
NCT ID NCT05333250
First seen Jun 27, 2026 · Last updated Jul 28, 2026 · Updated 2 times
Summary
This study tests whether modafinil, a drug that promotes wakefulness, can reduce severe fatigue and thinking problems in people with advanced cancer. About 40 adults with stage III or IV cancer will receive either modafinil or a placebo for a short time. The goal is to see if the drug helps and if a larger study is possible.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 18 years of age or older with stage III or IV cancer diagnosis 2. Estimated prognosis ≥ 3 months 3. Eastern Cooperative Oncology Group (ECOG) Score 0-2 4. 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) 5. Ability to understand and communicate in English 6. Ability to give first-person informed consent 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 * 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: 1. Methylphenidate 2. Cyclosporine 3. Propranolol 4. Phenytoin 5. S-mephenytoin 6. Warfarin 7. Triazolam 8. Ethinyl estradiol 9. Clomipramine 10. Midodrine 11. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Ottawa Hospital
RECRUITINGOttawa, Ontario, Canada
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