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

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00917748

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Depression Prostate Cancer

Drug Information available for: Modafinil Docetaxel

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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 ]

Estimated Enrollment:	138
Study Start Date:	July 2009
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Placebo Comparator 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

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

Contacts

Contact: Public Registry GMA

PublicRegistryGMA@sanofi-aventis.com

Locations

Australia
Sanofi-aventis Administrative Office	Recruiting
Macquarie Park, Australia

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Rosanna DUFFY

sanofi-aventis administrative office

More Information

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	DOCET_L_04203
Study First Received:	June 8, 2009
Last Updated:	September 3, 2009
ClinicalTrials.gov Identifier:	NCT00917748 History of Changes
Health Authority:	Australia: Human Research Ethics Committee

Additional relevant MeSH terms:

Skin Diseases
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Breast Neoplasms
Urogenital Neoplasms
Central Nervous System Stimulants
Genital Diseases, Male
Protective Agents

Neuroprotective Agents
Pharmacologic Actions
Modafinil
Docetaxel
Neoplasms
Neoplasms by Site
Therapeutic Uses
Central Nervous System Agents
Prostatic Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010