Testing Modafinil against a placebo for cancer-related cognitive difficulties
Official title: Modafinil to Improve Fatiguability
Modafinil to Improve Fatiguability (MODIFY): Modafinil vs. Placebo Vanguard RCT
- Phase 1
- 2 groups
- One site, in Ottawa
- Recruiting
Interventions
- Medication
Modafinil
Modafinil
- Other intervention
Placebo
Placebo
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario
Eligibility Criteria
See who this study is looking for39 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Eastern Cooperative Oncology Group (ECOG) Score 0-2
- +18 years of age or older with stage III or IV cancer diagnosis
- +Estimated prognosis ≥ 3 months
- +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
Exclusion
- −Simultaneous participation in another interventionalInterventional studyA study where participants are given something to see what happens.Read more → clinical study (e.g., Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more →-3 clinical studies) or treatment with any investigational medicinal product within 30 days prior to screening visitScreeningThe checks done before joining, to see whether a study fits.Read more → that could, in the judgment of the Qualified Medical InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, affect the patient's participation in or outcome of this clinical trial.
- −Allergy to modafinil or placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → contents
- −Known brain metastasis or primary brain tumor
- −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)
- −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
- −S-mephenytoin
- −Ethinyl estradiol
- −Clomipramine
- −Antipyrine
- −Inability to ingest oral capsule
- −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 participant unsuitable for this study.
- −Pregnancy or lactation, or trying to conceive
- −Currently receiving or have received cytotoxic chemotherapy in the last 6 weeks
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more →/2 — a combined study that starts with early safety and continues into what the treatment does.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Modafinil.
Registry label: A: Modafinil
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: B: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 40 people.
The study is currently expected to finish around March 2028.
The main measurement is taken over: 2 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Fatigue — measured over 2 weeks.
Fatigue — measured over 2 weeks.
Recruitment rate — measured over 2 years.
Completion of intervention — measured over 2 years.
The study lists 1 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05333250 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About ModafinilDrug
Modafinil
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboOther
Placebo
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 2 weeks.
The study as a whole is currently expected to finish around 2028-03.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 40 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Ottawa, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.