Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2025-12-24 @ 5:04 PM
NCT ID:
NCT05333250
Eligibility Criteria:
Inclusion Criteria:
* Stage III or IV cancer diagnosis;
* Has been off cytotoxic chemotherapy for at least 6 weeks;
* Eastern Cooperative Oncology Group (ECOG) score of 0-2;
* Experiencing CRF, defined as score of 4 or greater on the Fatigue item of the Edmonton Symptom Assessment System-revised (ESAS-r);
* Prognosis of at least 3 months;
* Able to understand and communicate in English and/or French;
* Able to give first-person informed consent.
Exclusion Criteria:
* Allergy to modafinil;
* Dose change of prednisone or dexamethasone in the past 7 days or planned dose change during study period;
* Received blood transfusion in the past 2 weeks;
* Hemoglobin lower than 80 g/L measured within 2 weeks of enrolment;
* Thyroid Stimulating Hormone (TSH) above normal range (measured within 2 weeks or start date);
* Patients with known brain metastasis or primary brain tumors;
* Documented dementia diagnosis;
* Documented major psychiatric illness including major depressive episode, bipolar disorder, or schizophrenia;
* Uncontrolled hypertension, defined as blood pressure higher than 140/80;
* Inability to ingest oral capsule;
* Pregnant or lactating;
* Severe liver dysfunction, defined as newly developed liver enzyme elevation total bilirubin \>3 upper limits of normal, aspartate aminotransferase or alanine aminotransferase \>5 upper limits of normal.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05333250
Study Brief:
Protocol Section:
NCT05333250