Modafinil to Improve Fatiguability
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Modafinil
- Placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ottawa Hospital Research Institute
Lead sponsor
The Ottawa Hospital
Collaborator
Source ClinicalTrials.gov