Status:
COMPLETED
Study With Modafinil in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer (MOTIF)
Lead Sponsor:
Sanofi
Conditions:
Prostatic Neoplasms
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective is: * To determine the efficacy of modafinil in the reduction of fatigue in patients with metastatic breast or prostate cancer undergoing docetaxel-based chemotherapy The secon...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00917748
Start Date
June 1 2009
End Date
March 1 2011
Last Update
September 26 2012
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Macquarie Park, Australia