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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00917748
First received: June 8, 2009
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

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

Condition Intervention Phase
Prostatic Neoplasms
Breast Cancer
Drug: DOCETAXEL(XRP6976) + MODAFINIL
Drug: Modafinil
Drug: Placebo of Modafinil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 [ Time Frame: From baseline to the end of study (week 12) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient quality of life weekly assessed by using the self-administered Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Quality Of Life survey [ Time Frame: From baseline to the end of study (week 12) ] [ Designated as safety issue: No ]
  • Fatigue assessed by using the self-administered six-item somatic subscale (SOMA) of the Somatic and Psychological Health Report (SPHERE) questionnaire [ Time Frame: At screening and from visit 6 (week 3) of treatment to end of study (week 12) ] [ Designated as safety issue: No ]
  • Sleep quality assessed by using the self-administered Pittsburgh Sleep Quality Index (PSQI) questionnaire [ Time Frame: At baseline and from visit 6 (week 3) to end of study (week 12) ] [ Designated as safety issue: No ]
  • Functional status will be determined using the self-administered Medical Outcomes Study - Short Form Health Survey (SF-36) [ Time Frame: At baseline and from visit 6 (week 3) to end of study (week 12) ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: At baseline and last visit= end of study (week 12) ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: June 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
docetaxel chemotherapy + modafinil 100 mg capsules
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
Drug: Modafinil
best supportive care (docetaxel chemotherapy) plus modafinil 200mg mane daily
Placebo Comparator: 2
docetaxel chemotherapy + placebo (lactose) capsules (matched to modafinil drug)
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
Drug: Placebo of Modafinil
Best supportive care (docetaxel chemotherapy) + placebo capsules one daily-mane (before noon)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00917748

Locations
Australia
Sanofi-Aventis Administrative Office
Macquarie Park, Australia
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Rosanna DUFFY Sanofi
  More Information

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00917748     History of Changes
Other Study ID Numbers: DOCET_L_04203
Study First Received: June 8, 2009
Last Updated: September 25, 2012
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Modafinil
Docetaxel
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 26, 2014