NCT00917748

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Prostatic Neoplasms
• Breast Cancer

Interventions

Type	Name	Description
DRUG	DOCETAXEL(XRP6976) + MODAFINIL	arm 1: best supportive care (docetaxel chemotherapy) plus modafinil 200mg mane daily arm 2: best supportive care (docetaxel chemotherapy) plus placebo of modafinil 200mg mane daily
DRUG	Modafinil	best supportive care (docetaxel chemotherapy) plus modafinil 200mg mane daily
DRUG	Placebo of Modafinil	Best supportive care (docetaxel chemotherapy) + placebo capsules one daily-mane (before noon)

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2009-06-10
• Last updated: 2012-09-26

Locations

1 site across 1 country: Australia