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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00917748
Ethics application status
Date submitted
8/06/2009
Date registered
9/06/2009
Date last updated
25/09/2012

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
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
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)

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)

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)
Primary outcome [2] 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 [2] 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)
Secondary outcome [6] 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 [6] 0 0
From baseline to the end of study (week 12)
Secondary outcome [7] 0 0
Fatigue assessed by using the self-administered six-item somatic subscale (SOMA) of the Somatic and Psychological Health Report (SPHERE) questionnaire
Timepoint [7] 0 0
At screening and from visit 6 (week 3) of treatment to end of study (week 12)
Secondary outcome [8] 0 0
Sleep quality assessed by using the self-administered Pittsburgh Sleep Quality Index (PSQI) questionnaire
Timepoint [8] 0 0
At baseline and from visit 6 (week 3) to end of study (week 12)
Secondary outcome [9] 0 0
Functional status will be determined using the self-administered Medical Outcomes Study - Short Form Health Survey (SF-36)
Timepoint [9] 0 0
At baseline and from visit 6 (week 3) to end of study (week 12)
Secondary outcome [10] 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 [10] 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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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

Summary results
Other publications