Overview

Study With Modafinil in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer (MOTIF)

Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
Participant gender:
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 secondary objectives are: - To determine the effect of modafinil on quality of life (QoL) during docetaxel-based chemotherapy - To determine the effect of modafinil on patients physical activity level, functional status, number of chemotherapy cycles tolerated, sleep disturbance and depression, during docetaxel-based chemotherapy - To investigate the impact of tumour type, patient physical activity level, functional status, sleep disturbance and depression on the efficacy of modafinil at improving fatigue and quality of life during docetaxel-based chemotherapy. - To determine the safety and tolerability of modafinil during docetaxel-based chemotherapy
Phase:
Phase 3
Details
Lead Sponsor:
Sanofi
Treatments:
Armodafinil
Docetaxel
Modafinil