Who is sponsoring NCT00917748?

NCT00917748 is sponsored by Sanofi.

What condition does NCT00917748 study?

NCT00917748 studies Prostatic Neoplasms, Breast Cancer.

What drugs are being tested in NCT00917748?

Interventions: DOCETAXEL(XRP6976) + MODAFINIL, Modafinil, Placebo of Modafinil.

What is the status of NCT00917748?

NCT00917748 is currently COMPLETED.

Last reviewed 2012-09-25 · How we verify

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

NCT00917748 Phase 3 COMPLETED

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

Details

Lead sponsor	Sanofi
Phase	Phase 3
Status	COMPLETED
Enrolment	84
Start date	2009-06
Completion	2011-03

Conditions

Prostatic Neoplasms
Breast Cancer

Interventions

DOCETAXEL(XRP6976) + MODAFINIL
Modafinil
Placebo of Modafinil

Primary outcomes

Fatigue scores daily assessed using the 11-point (0-10) 0 is the lower score and 10 is the highest. this score is calculated using the MD Anderson Symptom Inventory — From baseline to the end of study (week 12)

Countries

Australia