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

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-03-31

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

Conditions

Prostatic Neoplasms; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

docetaxel chemotherapy + modafinil 100 mg capsules

Group Type: EXPERIMENTAL

DOCETAXEL(XRP6976) + MODAFINIL

Intervention Type: DRUG

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

Intervention Type: DRUG

best supportive care (docetaxel chemotherapy) plus modafinil 200mg mane daily

2

docetaxel chemotherapy + placebo (lactose) capsules (matched to modafinil drug)

Group Type: PLACEBO_COMPARATOR

DOCETAXEL(XRP6976) + MODAFINIL

Intervention Type: DRUG

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

Intervention Type: DRUG

Best supportive care (docetaxel chemotherapy) + placebo capsules one daily-mane (before noon)

Interventions

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

Intervention Type: DRUG

Modafinil

best supportive care (docetaxel chemotherapy) plus modafinil 200mg mane daily

Intervention Type: DRUG

Placebo of Modafinil

Best supportive care (docetaxel chemotherapy) + placebo capsules one daily-mane (before noon)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rosanna DUFFY

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Macquarie Park, , Australia

Countries

Australia

References

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.

Reference Type: DERIVED

PMID: 24337761 (View on PubMed)

Other Identifiers

DOCET_L_04203

Identifier Type: -

Identifier Source: org_study_id