Modafinil for Cancer-Related Fatigue
(MODIFY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether modafinil can reduce fatigue and improve mental sharpness in people with advanced cancer. Participants will receive either modafinil or a placebo to determine its effect on energy levels and cognitive function. The trial targets individuals with stage III or IV cancer who experience significant fatigue and are no longer undergoing chemotherapy. Those who have stopped chemotherapy for at least six weeks and frequently feel tired may qualify for this study. As a Phase 3 trial, it represents the final step before FDA approval, providing an opportunity to contribute to a treatment that could soon become widely available.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but it does mention that you cannot participate if you've had a dose change of prednisone or dexamethasone in the past 7 days or plan to change the dose during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that modafinil is generally well-tolerated by patients and can help reduce tiredness in some cancer patients, particularly those with severe fatigue. However, its effectiveness varies, and some studies found no significant improvement in fatigue for certain groups.
Modafinil is already FDA-approved for other conditions like narcolepsy, indicating a certain level of safety. Some individuals might experience mild side effects, such as headaches or nausea. Participants should consult their healthcare provider about potential risks and benefits before joining a trial.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for cancer-related fatigue, which often focus on exercise, psychosocial interventions, or medications like corticosteroids, modafinil offers a different approach. Modafinil is unique because it is a wakefulness-promoting agent traditionally used to treat sleep disorders like narcolepsy. Researchers are excited about modafinil because it targets the brain's neurotransmitter systems, potentially improving alertness and energy levels more rapidly and effectively than current options. Additionally, its once-daily oral capsule makes it convenient for patients, possibly encouraging better adherence to treatment.
What evidence suggests that modafinil might be an effective treatment for cancer-related fatigue?
This trial will compare Modafinil with a placebo to evaluate its effectiveness in reducing cancer-related fatigue. Research has shown that Modafinil can help reduce tiredness in cancer patients. One study found it helped with fatigue in patients with brain and breast cancer, while another study found it significantly reduced daytime sleepiness in those with severe fatigue. However, a different study found no effect on fatigue in lung cancer patients. Overall, Modafinil seems promising for boosting energy levels, but its effectiveness can vary based on the type of cancer and the patient's condition.23456
Who Is on the Research Team?
James Downar, MDCM, MSc
Principal Investigator
The Ottawa Hospital
Edward Fitzgibbon, MD, MSc, CCFP(PC)
Principal Investigator
The Ottawa Hospital
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 200 mg of modafinil or placebo once daily for one week
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants' fatigue, cognition, and quality of life are assessed using validated questionnaires
What Are the Treatments Tested in This Trial?
Interventions
- Modafinil
- Placebo
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Two 100mg modafinil capsules once daily for 2 weeks
Two 100mg placebo capsules once daily for 2 weeks
Modafinil is already approved in United States, European Union, Canada for the following indications:
- Narcolepsy
- Shift Work Sleep Disorder
- Obstructive Sleep Apnea
- Excessive daytime sleepiness associated with narcolepsy
- Shift work sleep disorder
- Obstructive sleep apnea
- Narcolepsy
- Shift Work Sleep Disorder
- Obstructive Sleep Apnea
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ottawa Hospital Research Institute
Lead Sponsor
Bruyère Health Research Institute.
Collaborator
Bruyere Research Institute
Collaborator
The Ottawa Hospital
Collaborator
Citations
NCT01440621 | Modafinil in Cancer Related Fatigue
Secondary outcomes include Quality of Life, improvements in performance status, changes in systolic and diastolic blood pressure, and changes in weight.
Modafinil Moderates the Relationship between Cancer ...
Modafinil differentially impacts depression based on a patient's level of fatigue, and reduced depressive symptoms only in those with extreme fatigue.
A Phase III Randomized, Placebo-Controlled, Double-Blind ...
Previous open label studies reported that modafinil helped alleviate CRF following cancer treatment in 30 brain cancer patients and 51 breast cancer patients.
Modafinil for the Treatment of Fatigue in Lung Cancer
Conclusion. Modafinil had no effect on cancer-related fatigue and should not be prescribed outside a clinical trial setting. Its use was associated with a ...
Modafinil
In cancer populations: A preliminary placebo-controlled trial resulted in significantly reduced daytime sleepiness in patients with severe CRF ...
Efficacy and safety of modafinil in the treatment of cancer- ...
Clinical data demonstrate that modafinil significantly reduces fatigue in patients who have received cancer treatment or are currently undergoing chemotherapy.
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