Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | Study With Modafinil in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer (MOTIF)
