A Prospective, Randomised, Double-Blind, Placebo-Controlled Phase III Study of Modafinil to Improve Fatigue and Quality of Life in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer
Inclusion Criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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.