Modafinil for Cancer-Related Fatigue

(MODIFY Trial)

Overseen By Shainuka Kannathas, HBSc

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Prednisone, Dexamethasone

Disqualifiers: Brain metastasis, Dementia, Psychiatric illness, Hypertension, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 week

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. ^{1 2 3 4 5}

Why 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. ^{2 3 4 5 6}

Who Is on the Research Team?

Edward Fitzgibbon, MD, MSc

Principal Investigator

The Ottawa Hospital

James Downar, MDCM, MSc

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

My cancer is at stage III or IV.

I can understand and communicate in English or French.

Able to give first-person informed consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive 200 mg of modafinil or placebo once daily for one week

1 week

Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

Long-term Follow-up

Participants' fatigue, cognition, and quality of life are assessed using validated questionnaires

2 years

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?

Group I: Modafinil Experimental Treatment 1 Intervention

One 200mg modafinil capsule once daily for one week

Group II: Placebo Placebo Group 1 Intervention

One placebo capsule once daily for one week

Modafinil is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Provigil for:

• Narcolepsy
• Shift Work Sleep Disorder
• Obstructive Sleep Apnea

Approved in European Union as Modafinil for:

• Excessive daytime sleepiness associated with narcolepsy
• Shift work sleep disorder
• Obstructive sleep apnea

Approved in Canada as Alertec for:

• Narcolepsy
• Shift Work Sleep Disorder
• Obstructive Sleep Apnea

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Bruyère Health Research Institute.

Collaborator

Bruyere Research Institute

Collaborator

Trials

35

Recruited

2,024,000+

The Ottawa Hospital

Collaborator

Trials

97

Recruited

64,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01440621?cond=Modafinil&viewType=Table&rank=9

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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4689625/

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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2941794/

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.

4. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2013.54.4346?role=tab

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 ...

5. mypcnow.org mypcnow.org/fast-fact/modafinil/

Modafinil In cancer populations: A preliminary placebo-controlled trial resulted in significantly reduced daytime sleepiness in patients with severe CRF ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19318599/

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.