RecruitingPhase 1/2

Modafinil to Improve Fatiguability

Canada40 participantsStarted 2026-01-22

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. Methylphenidate
✕. Cyclosporine
✕. Propranolol
✕. Phenytoin
✕. S-mephenytoin
✕. Warfarin
✕. Triazolam
✕. Ethinyl estradiol

What they're measuring

Fatigue

Timeframe: 2 weeks

Fatigue

Timeframe: 2 weeks

Recruitment rate

Timeframe: 2 years

Completion of intervention

Timeframe: 2 years

Completion of follow-up

Timeframe: 2 years

Trial details

NCT IDNCT05333250

SponsorOttawa Hospital Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10

Contact for this trial

Shainuka Kannathas, HBSc

(613) 562-6262 shkannathas@ohri.ca

View on ClinicalTrials.gov More Cancer-related Cognitive Difficulties trials