Lead Sponsor

Sanofi

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Treatment with q3w (every three weeks) docetaxel-based chemotherapy for metastatic breast or prostate cancer at a minimum dose of 50 mg/m2
•Completed at least two cycles of chemotherapy and intention to treat the patient with at least two further cycles of docetaxel-based chemotherapy
•Fatigue \> or = to 4 on the MD Anderson Symptom Inventory fatigue assessment scale during the previous docetaxel chemotherapy cycle
•SPHERE somatic (SOMA) subscale score \> or = to 3
•Worsening of fatigue after commencement of docetaxel chemotherapy
•Haemoglobin (Hb)\> or = to 10 g/dL within two weeks before randomisation

•Unable to complete the MD Anderson Symptom Inventory fatigue assessment scale or Functional Assessment of Chronic Illness Therapy-Fatigue Quality of Life survey
•Require docetaxel chemotherapy dose reduction to less than 50 mg/m2
•History of chronic fatigue condition
•Uncontrolled hypertension (blood pressure \> or = to 150/90 mm Hg
•Known hypersensitivity / intolerance to modafinil or any of the excipients
•Pregnant women
•Psychological, familial, sociological, or geographical conditions that do not permit treatment or medical follow-up and / or prohibit compliance with the study protocol
•Any serious concomitant illness that, in the opinion of the Investigator, would preclude a patient from participating in the study
•Non-English speaking
•The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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