Prostatic NeoplasmsPhase 3NCT00917748
Study With Modafinil in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer (MOTIF)
A Phase 3 study testing DOCETAXEL(XRP6976) + MODAFINIL and Modafinil in people with Prostatic Neoplasms and Breast Cancer, run by Sanofi at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostatic Neoplasms, Breast Cancer
- What is being tested?
- DOCETAXEL(XRP6976) + MODAFINIL and Modafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2009to Mar 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this 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
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
Read more
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
- Conditions
- Prostatic Neoplasms, Breast Cancer
- Being tested
- DOCETAXEL(XRP6976) + MODAFINIL, Modafinil, Placebo of Modafinil
- Medical subject headings
- Prostatic Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOCETAXEL(XRP6976) + MODAFINILDrug
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
ModafinilDrug
best supportive care (docetaxel chemotherapy) plus modafinil 200mg mane daily
Placebo of ModafinilDrug
Best supportive care (docetaxel chemotherapy) + placebo capsules one daily-mane (before noon)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | docetaxel chemotherapy + modafinil 100 mg capsules Receives: Drug: DOCETAXEL(XRP6976) + MODAFINIL; Drug: Modafinil |
| 2 | Placebo comparator | docetaxel chemotherapy + placebo (lactose) capsules (matched to modafinil drug) Receives: Drug: DOCETAXEL(XRP6976) + MODAFINIL; Drug: Placebo of Modafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline to the end of study (week 12)
Secondary outcomes (5)
Patient quality of life weekly assessed by using the self-administered Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Quality Of Life survey
Measured: From baseline to the end of study (week 12)
Fatigue assessed by using the self-administered six-item somatic subscale (SOMA) of the Somatic and Psychological Health Report (SPHERE) questionnaire
Measured: At screening and from visit 6 (week 3) of treatment to end of study (week 12)
Sleep quality assessed by using the self-administered Pittsburgh Sleep Quality Index (PSQI) questionnaire
Measured: At baseline and from visit 6 (week 3) to end of study (week 12)
Functional status will be determined using the self-administered Medical Outcomes Study - Short Form Health Survey (SF-36)
Measured: At baseline and from visit 6 (week 3) to end of study (week 12)
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
Measured: At baseline and last visit= end of study (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rosanna DUFFY, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917748
- Sponsor's protocol ID
- DOCET_L_04203
- Status last verified
- Sep 2012
- First submitted
- 8 Jun 2009
- Last updated
- 26 Sep 2012
- Results posted
- No
Publications
Hovey E, de Souza P, Marx G, Parente P, Rapke T, Hill A, Bonaventura A, Michele A, Craft P, Abdi E, Lloyd A; MOTIF investigators. Phase III, randomized, double-blind, placebo-controlled study of modafinil for fatigue in patients treated with docetaxel-based chemotherapy. Support Care Cancer. 2014 May;22(5):1233-42. doi: 10.1007/s00520-013-2076-0. Epub 2013 Dec 17.
PubMed 24337761
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00917748
- Acronym / sponsor ID
- DOCET_L_04203
- Conditions
- Prostatic Neoplasms, Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DOCETAXEL(XRP6976) + MODAFINIL, Drug: Modafinildocetaxel chemotherapy + modafinil 100 mg capsules |
| 2 | Placebo comparator | Drug: DOCETAXEL(XRP6976) + MODAFINIL, Drug: Placebo of Modafinildocetaxel chemotherapy + placebo (lactose) capsules (matched to modafinil drug) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DOCETAXEL(XRP6976) + MODAFINILarm 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 | 1, 2 |
| Modafinilbest supportive care (docetaxel chemotherapy) plus modafinil 200mg mane daily | Drug | 1 |
| Placebo of ModafinilBest supportive care (docetaxel chemotherapy) + placebo capsules one daily-mane (before noon) | Drug | 2 |
Primary outcome
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)
5 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2012.
- Derived from this study: PubMed 24337761Hovey E, de Souza P, Marx G, Parente P, Rapke T, Hill A, Bonaventura A, Michele A, Craft P, Abdi E, Lloyd A; MOTIF investigators. Phase III, randomized, double-blind, placebo-controlled study of modafinil for fatigue in patients treated with docetaxel-based chemotherapy. Support Care Cancer. 2014 May;22(5):1233-42. doi: 10.1007/s00520-013-2076-0. Epub 2013 Dec 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosanna DUFFY study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DOCETAXEL(XRP6976) + MODAFINIL and Modafinil in people with Prostatic Neoplasms and Breast Cancer, run by Sanofi at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: From baseline to the end of study (week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00917748, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2012.