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CNS Stimulant
Modafinil for Cancer-Related Fatigue
N/A
Waitlist Available
Led By Leslie Blackhall, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Brief Fatigue Inventory score ≥ 4
Performance status ECOG 1-3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing whether modafinil can help relieve fatigue and improve quality of life in cancer patients.
Who is the study for?
This trial is for cancer patients experiencing fatigue, aged 18 or older, with a life expectancy of at least 2 months. They should be able to perform daily activities with some limitations (ECOG status 1-3) and not have severe heart issues, psychosis, or other conditions that could affect study participation. Pregnant women and those allergic to modafinil cannot join.Check my eligibility
What is being tested?
The trial is testing the effectiveness of modafinil in reducing fatigue among cancer patients. It aims to improve their quality of life by assessing how well they respond to this medication compared to their current state without it.See study design
What are the potential side effects?
Potential side effects of modafinil may include headache, nausea, nervousness, dizziness, difficulty sleeping, and possibly more serious effects like irregular heartbeat or mood changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I often feel very tired.
Select...
I have some limitations but can still take care of myself.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fatigue as measured by Brief Fatigue Inventory at 2 and 4 weeks after the start of treatment
Safety, in terms of adverse events and dose-limiting toxicity, as measured by NCI CTC v2.0 at up to 4 weeks after the start of treatment
Secondary outcome measures
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Controlled Oral Word Association Test from the Multilingual Aphasia Examination at 2 and 4 weeks after start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Grooved Pegboard Test at 2 and 4 weeks after start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Hopkins Verbal Learning Test at 2 and 4 weeks after start of treatment
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Who is running the clinical trial?
University of VirginiaLead Sponsor
748 Previous Clinical Trials
1,236,003 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,646 Total Patients Enrolled
118 Trials studying Fatigue
18,531 Patients Enrolled for Fatigue
Leslie Blackhall, MDPrincipal InvestigatorUniversity of Virginia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am at least 18 years old.I often feel very tired.I have some limitations but can still take care of myself.I have been diagnosed with cancer.I often feel very tired.My daily activity level is good.I have never had chest pain.I have never had heart valve issues from using CNS stimulants.My heart's left ventricle is not thickened.I have never had an irregular heartbeat.I am currently taking painkillers, antipsychotics, or anxiety medication.I don't have any chronic conditions or mental health issues that would stop me from participating in the study.I am 18 years old or older.I have been diagnosed with cancer.I have some limitations but can still take care of myself.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies available for those wishing to participate in this research?
"The clinicaltrials.gov website reveals that, as of now, this medical trial is not actively seeking participants despite being posted on February 1st 2004 and last updated August 19th 2009. Despite this, there are still over thirteen hundred other studies currently searching for volunteers to join their trials."
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Who else is applying?
What state do they live in?
Virginia
What portion of applicants met pre-screening criteria?
Met criteria
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