Modafinil to reduce fatigue and thinking problems in advanced cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Vanguard randomized, placebo-controlled phase 1/2 trial at The Ottawa Hospital compares modafinil with placebo in adults with stage III or IV cancer experiencing clinically significant cancer-related fatigue. Participants are randomized to receive modafinil or matching placebo and are followed to measure changes in fatigue severity and cognitive function while collecting feasibility data such as recruitment and retention. Key inclusion criteria include age ≥18, ECOG 0–2, prognosis ≥3 months, and an ESAS-r-cs fatigue score ≥4, and key exclusions include recent cytotoxic chemotherapy, severe liver dysfunction, and contraindications to modafinil. The trial aims to estimate effect sizes for fatigue and cognitive outcomes and determine whether a larger definitive trial is feasible.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Ottawa Hospital
  Ottawa, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Edward Fitzgibbon, MD, MSc, CCFP(PC) — The Ottawa Hospital
• Study coordinator: Shainuka Kannathas, HBSc
• Email: shkannathas@ohri.ca
• Phone: (613) 562-6262

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.