Clinical trial NCT00917748: Study With Modafinil in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer (MOTIF)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostatic Neoplasms
Breast Cancer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-06-10
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: From baseline to the end of study (week 12)
Secondary outcomes:
measure: Patient quality of life weekly assessed by using the self-administered Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Quality Of Life survey
timeFrame: From baseline to the end of study (week 12)
measure: Fatigue assessed by using the self-administered six-item somatic subscale (SOMA) of the Somatic and Psychological Health Report (SPHERE) questionnaire
timeFrame: At screening and from visit 6 (week 3) of treatment to end of study (week 12)
measure: Sleep quality assessed by using the self-administered Pittsburgh Sleep Quality Index (PSQI) questionnaire
timeFrame: At baseline and from visit 6 (week 3) to end of study (week 12)
measure: Functional status will be determined using the self-administered Medical Outcomes Study - Short Form Health Survey (SF-36)
timeFrame: At baseline and from visit 6 (week 3) to end of study (week 12)
measure: 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
timeFrame: At baseline and last visit= end of study (week 12)
Other outcomes:
Locations:
city: Macquarie Park
country: Australia
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Rosanna DUFFY
role: STUDY_DIRECTOR
References:
citation: Hovey E, de Souza P, Marx G, Parente P, Rapke T, Hill A, Bonaventura A, Michele A, Craft P, Abdi E, Lloyd A; MOTIF investigators. Phase III, randomized, double-blind, placebo-controlled study of modafinil for fatigue in patients treated with docetaxel-based chemotherapy. Support Care Cancer. 2014 May;22(5):1233-42. doi: 10.1007/s00520-013-2076-0. Epub 2013 Dec 17.