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

Condition(s) targeted: Prostatic Neoplasms; Breast Cancer

Intervention: DOCETAXEL(XRP6976) + MODAFINIL (Drug); Modafinil (Drug); Placebo of Modafinil (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Rosanna DUFFY, Study Director, Affiliation: sanofi-aventis administrative office

Overall contact:
Public Registry GMA, Email: PublicRegistryGMA@sanofi-aventis.com

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

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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

Secondary outcome:

Patient quality of life weekly assessed by using the self-administered Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Quality Of Life survey

Fatigue assessed by using the self-administered six-item somatic subscale (SOMA) of the Somatic and Psychological Health Report (SPHERE) questionnaire

Sleep quality assessed by using the self-administered Pittsburgh Sleep Quality Index (PSQI) questionnaire

Functional status will be determined using the self-administered Medical Outcomes Study - Short Form Health Survey (SF-36)

Depression assessed using seven depression-related questions from the self-administered Hospital Anxiety and Depression (HAD) assessment subscale. Patient with depression will be defined as having the HAD-D> or = 8

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Public Registry GMA, Email: PublicRegistryGMA@sanofi-aventis.com

Sanofi-aventis Administrative Office, Macquarie Park, Australia; Recruiting

Starting date: July 2009
Ending date: August 2010
Last updated: September 3, 2009