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

NCT00917748 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2012-09-26

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Rosanna DUFFY · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • Australia

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00917748 on ClinicalTrials.gov