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New treatment option for Cancer-related Cognitive Difficulties
Official title Modafinil to Improve Fatiguability
ClinicalTrials.gov ID: NCT05333250
What this study is testing
What is Modafinil?
Modafinil is an investigational medicine, given as an once-daily, being studied as a potential treatment for cancer-related cognitive difficulties.
Also referred to as Provigil.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Ability to understand and communicate in English
You likely can't join if
- 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
- Hemoglobin lower than 80 g/L measured in the last 4 weeks
- TSH above normal range in the last 4 weeks
See the full eligibility criteria
- 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)
- Ability to understand and communicate in English
- Ability to give first-person informed consent
- 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
- Hemoglobin lower than 80 g/L measured in the last 4 weeks
- TSH above normal range in the last 4 weeks
- Severe liver dysfunction (total bilirubin \>3x upper limit of normal, or aspartate aminotransferase or alanine aminotransferase \>5x upper limit of normal)
- Known brain metastasis or primary brain tumor
- Documented dementia diagnosis
- Documented major psychiatric illness including major depressive episode, bipolar disorder, schizophrenia
- Uncontrolled hypertension as defined by a blood pressure greater than 140/90mmHg
- Unstable angina
- Recent (\<6 months previous) myocardial infarction
- Evidence of left ventricular hypertrophy or ischemia on ECG
- Arrythmia (e.g., atrial fibrillation)
- Coronary artery disease with Canadian Cardiovascular Society Symptoms Class \>1
- Taking high dose selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants
- Taking any benzodiazepine at any dose
- Taking any amphetamine at any dose
- Taking any monoamine oxidase inhibitor (MAOI) at any dose
- Taking any azole anti-fungal medication (e.g., fluconazole, itraconazole, or ketoconazole)
- Taking any of the following medications at any dose:
- Methylphenidate
- Cyclosporine
- Propranolol
- Phenytoin
- S-mephenytoin
- Warfarin
- Triazolam
- Ethinyl estradiol
- Clomipramine
- Midodrine
- Antipyrine
- Inability to ingest oral capsule
- Pregnancy or lactation, or trying to conceive
- Any other history, condition, therapy, or uncontrolled intercurrent illness which could, in the opinion of the Qualified Medical Investigator, affect compliance with study requirements or which would make the...
- Simultaneous participation in another treatment clinical study (e.g., Phase 1-3 clinical studies) or treatment with any investigational medicinal product within 30 days prior to screening visit that could, in the...
The study team makes the final eligibility decision.
Where it's taking place
- Ottawa, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ottawa, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.