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Completed

NCT Number: NCT00917748

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

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

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Key information

Conditions

Prostatic Neoplasms Breast Cancer Breast Diseases Breast Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office

Macquarie Park, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DOCETAXEL(XRP6976) + MODAFINIL

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

Drug

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

Placebo of Modafinil

Drug

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 10, 2009
Registry last updated
Sep 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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