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

40 Participants Needed

Trial Summary

What is the purpose of 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.

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.

What data supports the effectiveness of the drug modafinil for cancer-related fatigue?

Research shows that modafinil can significantly reduce fatigue in cancer patients, as seen in a study where patients experienced a rapid and significant reduction in fatigue. Another study found that modafinil was slightly more effective than dexamethasone, another drug used for fatigue, in improving quality of life for cancer patients. ^{1 2 3 4 5}

How does the drug modafinil differ from other treatments for cancer-related fatigue?

Modafinil is unique because it is a central nervous system stimulant that selectively targets the brain, making it better tolerated than traditional stimulants like methylphenidate. It has shown to be effective in reducing fatigue and improving quality of life in cancer patients, with a daily dosage of 100-200 mg, and is considered safe and well-tolerated. ^{1 2 3 4 5}

Research Team

Edward Fitzgibbon, MD, MSc

Principal Investigator

The Ottawa Hospital

James Downar, MDCM, MSc

Principal Investigator

The Ottawa Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Bruyere Research Institute

Collaborator

Trials

35

Recruited

2,024,000+

The Ottawa Hospital

Collaborator

Trials

97

Recruited

64,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

A phase 3 randomized, placebo-controlled, double-blind, clinical trial of the effect of modafinil on cancer-related fatigue among 631 patients receiving chemotherapy: a University of Rochester Cancer Center Community Clinical Oncology Program Research base study. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Modafinil for the treatment of fatigue in lung cancer: a pilot study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of modafinil versus dexamethasone in cancer-related fatigue: a prospective randomized controlled study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Modafinil for the treatment of fatigue in lung cancer: results of a placebo-controlled, double-blind, randomized trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of modafinil in the treatment of cancer-related fatigue. [2018]