Modafinil to Improve Fatiguability

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · Apr 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called modafinil to see if it can help improve fatigue and cognitive difficulties in patients with advanced cancer. Many people with cancer often feel extremely tired and have trouble thinking clearly, but there aren’t many effective treatments available. The researchers want to find out if modafinil can make a difference for these symptoms and also check how easy it is to conduct this kind of study.

To be eligible for this trial, participants should have stage III or IV cancer and have not received certain types of chemotherapy for at least six weeks. They also need to have a specific level of fatigue and be able to communicate in English or French. Participants will need to give their consent to join the study and be in good enough health to take part. This trial is not yet recruiting participants, but it aims to help improve the quality of life for those dealing with the challenges of cancer-related fatigue and cognitive issues.

Gender

ALL

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.