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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917748
• Other study ID #: DOCET_L_04203
• Status: Completed
• Phase: Phase 3
• First received: June 8, 2009
• Last updated: September 25, 2012
• Start date: June 2009
• Est. completion date: March 2011

Study information

• Verified date: September 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Prostatic Neoplasms

Intervention

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
• Modafinil
best supportive care (docetaxel chemotherapy) plus modafinil 200mg mane daily
• Placebo of Modafinil
Best supportive care (docetaxel chemotherapy) + placebo capsules one daily-mane (before noon)

Locations

Country	Name	City	State
Australia	Sanofi-Aventis Administrative Office	Macquarie Park

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Patient quality of life weekly assessed by using the self-administered Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Quality Of Life survey		From baseline to the end of study (week 12)	No
Secondary	Fatigue assessed by using the self-administered six-item somatic subscale (SOMA) of the Somatic and Psychological Health Report (SPHERE) questionnaire		At screening and from visit 6 (week 3) of treatment to end of study (week 12)	No
Secondary	Sleep quality assessed by using the self-administered Pittsburgh Sleep Quality Index (PSQI) questionnaire		At baseline and from visit 6 (week 3) to end of study (week 12)	No
Secondary	Functional status will be determined using the self-administered Medical Outcomes Study - Short Form Health Survey (SF-36)		At baseline and from visit 6 (week 3) to end of study (week 12)	No
Secondary	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		At baseline and last visit= end of study (week 12)	No

External Links

•   Results summary