Breast Cancer, Prostatic Neoplasms
Conditions
Brief 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
Interventions
DRUGDOCETAXEL(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
DRUGModafinil
best supportive care (docetaxel chemotherapy) plus modafinil 200mg mane daily
DRUGPlacebo of Modafinil
Best supportive care (docetaxel chemotherapy) + placebo capsules one daily-mane (before noon)
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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) |
Countries
Australia
Outcome results
None listed