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Modafinil to Improve Fatiguability

NCT05333250 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-13

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Modafinil

Modafinil

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • The Ottawa Hospital

    collaborator OTHER

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Edward Fitzgibbon, MD, MSc, CCFP(PC) · The Ottawa Hospital

  • James Downar, MDCM, MHSc · The Ottawa Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-22
Primary Completion
2027-10-31
Completion
2028-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05333250 on ClinicalTrials.gov