Study With Modafinil in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer (MOTIF)
NCT ID: NCT00917748
Last Updated: 2012-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
84 participants
INTERVENTIONAL
2009-06-30
2011-03-31
Brief Summary
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* 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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
docetaxel chemotherapy + modafinil 100 mg capsules
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
2
docetaxel chemotherapy + placebo (lactose) capsules (matched to modafinil 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
Placebo of Modafinil
Best supportive care (docetaxel chemotherapy) + placebo capsules one daily-mane (before noon)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Rosanna DUFFY
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Macquarie Park, , Australia
Countries
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References
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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.
Other Identifiers
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DOCET_L_04203
Identifier Type: -
Identifier Source: org_study_id