Modafinil to Improve Fatiguability

Sponsor
Ottawa Hospital Research Institute
Study ID
NCT05333250
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Cancer-related Cognitive Difficulties
  • Cancer-related Problem/Condition
  • Fatigue

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Modafinil — DRUG
    Modafinil
  • Placebo — OTHER
    Placebo

Study Details

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.

Key Dates

First listed
Apr 18, 2022
Start date
Jan 22, 2026
Status verified
Jan 2026
Primary completion
Oct 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Modafinil
    Two 100mg modafinil capsules once daily for 2 weeks
  • Placebo Comparator: Placebo
    Two 100mg placebo capsules once daily for 2 weeks

Primary Outcome Measure

Fatigue [ Time Frame: 2 weeks ]

Central Contacts

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