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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00917748




Registration number
NCT00917748
Ethics application status
Date submitted
8/06/2009
Date registered
10/06/2009
Date last updated
26/09/2012

Titles & IDs
Public title
Study With Modafinil in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer (MOTIF)
Scientific 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
Secondary ID [1] 0 0
DOCET_L_04203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms 0 0
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DOCETAXEL(XRP6976) + MODAFINIL
Treatment: Drugs - Modafinil
Treatment: Drugs - Placebo of Modafinil

Experimental: 1 - docetaxel chemotherapy + modafinil 100 mg capsules

Placebo Comparator: 2 - docetaxel chemotherapy + placebo (lactose) capsules (matched to modafinil drug)


Treatment: Drugs: 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

Treatment: Drugs: Modafinil
best supportive care (docetaxel chemotherapy) plus modafinil 200mg mane daily

Treatment: Drugs: Placebo of Modafinil
Best supportive care (docetaxel chemotherapy) + placebo capsules one daily-mane (before noon)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
From baseline to the end of study (week 12)
Secondary outcome [1] 0 0
Patient quality of life weekly assessed by using the self-administered Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Quality Of Life survey
Timepoint [1] 0 0
From baseline to the end of study (week 12)
Secondary outcome [2] 0 0
Fatigue assessed by using the self-administered six-item somatic subscale (SOMA) of the Somatic and Psychological Health Report (SPHERE) questionnaire
Timepoint [2] 0 0
At screening and from visit 6 (week 3) of treatment to end of study (week 12)
Secondary outcome [3] 0 0
Sleep quality assessed by using the self-administered Pittsburgh Sleep Quality Index (PSQI) questionnaire
Timepoint [3] 0 0
At baseline and from visit 6 (week 3) to end of study (week 12)
Secondary outcome [4] 0 0
Functional status will be determined using the self-administered Medical Outcomes Study - Short Form Health Survey (SF-36)
Timepoint [4] 0 0
At baseline and from visit 6 (week 3) to end of study (week 12)
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
At baseline and last visit= end of study (week 12)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2011
Sample size
Target
Accrual to date
Final
84
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sanofi-Aventis Administrative Office - Macquarie Park
Recruitment postcode(s) [1] 0 0
- Macquarie Park

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00917748
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rosanna DUFFY
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries