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CNS Stimulant

Modafinil for Cancer-Related Fatigue (MODIFY Trial)

Phase 3
Waitlist Available
Led By Edward Fitzgibbon, MD, MSc
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to understand and communicate in English and/or French;
Stage III or IV cancer diagnosis;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

MODIFY Trial Summary

This trial will test if modafinil can help manage cancer-related fatigue and cognitive impairment, and if the study is feasible to carry out.

Who is the study for?
This trial is for adults with advanced (Stage III or IV) cancer who are not currently on cytotoxic chemotherapy and have been off it for at least a month. They should be experiencing significant fatigue, able to communicate in English or French, and capable of giving informed consent. A life expectancy of at least three months is required.Check my eligibility
What is being tested?
The study tests whether Modafinil can help manage severe fatigue and cognitive issues related to cancer. Participants will either receive Modafinil or a placebo without knowing which one they're getting, to compare the effects fairly.See study design
What are the potential side effects?
Modafinil may cause headaches, nausea, nervousness, dizziness, difficulty sleeping, and sometimes more serious side effects like skin rashes or allergic reactions.

MODIFY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can understand and communicate in English or French.
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My cancer is at stage III or IV.
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I am able to get out of my bed or chair and move around.
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I often feel very tired, scoring 4 or more on a fatigue scale.

MODIFY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Completion of follow-up
Completion of intervention
Fatigue
+1 more
Secondary outcome measures
Adverse events
Cognition
Patient satisfaction with MFI
+1 more

MODIFY Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ModafinilExperimental Treatment1 Intervention
One 200mg modafinil capsule once daily for one week
Group II: PlaceboPlacebo Group1 Intervention
One placebo capsule once daily for one week
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Modafinil
FDA approved

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,454 Total Patients Enrolled
2 Trials studying Fatigue
105 Patients Enrolled for Fatigue
Bruyere Research InstituteOTHER
34 Previous Clinical Trials
2,024,179 Total Patients Enrolled
The Ottawa HospitalOTHER
93 Previous Clinical Trials
62,878 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study's age limit allow for octogenarians?

"The minimum age for enrollment in this clinical trial is 18, with the maximum age being set at 75."

Answered by AI

Are there any open slots for new participants in this research?

"This is an inactive trial, as indicated by the information available on clinicaltrials.gov. This study was originally posted on May 1st, 2022 and was most recently edited on April 13th, 2022. There are currently 224 other trials searching for candidates."

Answered by AI

What is the eventual goal of this research?

"The main goal of this trial, which will take place over the course of a week, is to see how patients respond to the intervention. Additionally, researchers will also be measuring things like patient satisfaction with fatigue levels, any adverse effects experienced during the trial, and changes in cognition scores."

Answered by AI

What is the current FDA status of Modafinil?

"Modafinil has received a safety score of 3 from our team at Power. This is due to the fact that this medication has progressed to Phase 3 clinical trials, which demonstrates some efficacy and multiple rounds of data supporting safety."

Answered by AI

Might I be eligible to join this research project?

"This trial is currently looking for 40 individuals that suffer from fatigue and are between the ages of 18-75. The most important criteria that applicants must meet are as follows: a) A score of 4 or greater on the Fatigue item of the Edmonton Symptom Assessment System-revised (ESAS-r), b) The ability to understand and communicate in English and/or French, c) The ability to give first-person informed consent, d) A prognosis of at least 3 months, e) Stage III or IV cancer diagnosis, f) Has been off cytotoxic chemotherapy for at least 1 month, g)"

Answered by AI
Recent research and studies
~27 spots leftby Mar 2026