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

Study Overview
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Brief Summary
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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
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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

Conditions
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Prostatic Neoplasms, Breast Cancer

Intervention / Treatment
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* Drug: DOCETAXEL(XRP6976) + MODAFINIL
* Drug: Modafinil
* Drug: Placebo of Modafinil


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>docetaxel chemotherapy + modafinil 100 mg capsules | Drug: DOCETAXEL(XRP6976) + MODAFINIL<br>* 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<br>Drug: Modafinil<br>* best supportive care (docetaxel chemotherapy) plus modafinil 200mg mane daily<br>|
| Placebo Comparator: 2<br>docetaxel chemotherapy + placebo (lactose) capsules (matched to modafinil drug) | Drug: DOCETAXEL(XRP6976) + MODAFINIL<br>* 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<br>Drug: Placebo of Modafinil<br>* Best supportive care (docetaxel chemotherapy) + placebo capsules one daily-mane (before noon)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) |