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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Prostatic Neoplasms, Breast Cancer

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Trial Information

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

Inclusion 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.

Type of Study:

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

Outcome 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

Outcome Time Frame:

From baseline to the end of study (week 12)

Safety Issue:

No

Principal Investigator

Rosanna DUFFY

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Australia: Human Research Ethics Committee

Study ID:

DOCET_L_04203

NCT ID:

NCT00917748

Start Date:

June 2009

Completion Date:

March 2011

Related Keywords:

  • Prostatic Neoplasms
  • Breast Cancer
  • Breast Neoplasms
  • Neoplasms
  • Prostatic Neoplasms

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