FatiguePhase 2NCT00825227
Safety and Efficacy of Armodafinil for Fatigue Associated With Taxanes Alone or in Combination With Other Agents
A Phase 2 study testing Armodafinil 150 mg/day in people with Fatigue and Chemotherapy Side Effects, run by Cephalon at 29 sites in United States.
Trial summary
Evaluate the Safety and Efficacy of Armodafinil Treatment for Patients With Fatigue Associated With Taxane Chemotherapy Alone or in Combination With Other Agents Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fatigue, Chemotherapy Side Effects
- What is being tested?
- Armodafinil 150 mg/day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 29 sitesUnited States
- Study dates
- Dec 2008to Feb 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- The patient has cancer and is receiving, or is scheduled to receive, taxane chemotherapy (paclitaxel, docetaxel, or albumin-bound paclitaxel), either alone or in combination with other agents.
- The patient experiences an average score of 6 or greater for the daily worst fatigue severity assessment during screening.
- The patient has a life expectancy of at least 6 months.
- The patient is able to use the wrist actigraphy device or provide written documentation during the screening period.
- The patient has stable hemoglobin (≥10 g/dL) throughout the screening period.
- Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception (including abstinence) and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
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- Men not surgically sterile or who are capable of producing offspring must practice abstinence or use a barrier method of birth control, and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
- The patient has adequate hepatic and renal function.
- The patient meets the proposed diagnostic criteria for cancer-related fatigue as included in the International Classifications of Disease, Tenth Revision, Clinical Modification (ICD-10-CM).
- If the patient is taking any other chronic medication which may affect fatigue (e.g., antidepressants, anxiolytics, opioid analgesics), the dose has been stable for at least 4 weeks prior to screening and is expected to remain stable during the study.
Who cannot join
- The patient has any untreated reversible medical condition which may cause fatigue (e.g., metabolic disturbance, infection, endocrine abnormalities).
- The patient has received concurrent stimulant medication (e.g., dextroamphetamine or methylphenidate) during the screening period or double-blind treatment period.
- The patient has received concurrent modafinil during the screening period or double-blind treatment period.
- The patient has any delay in chemotherapy treatment such that the screening period extends beyond 6 weeks.
- The patient has known central nervous system (CNS) involvement by metastatic cancer.
- The patient is receiving concurrent radiation therapy (except for palliative radiation) or treatment with another investigational agent.
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- The patient has any serious, uncontrolled, non-malignant medical or psychiatric disorder that could impair the conduct of the study or the safety of the patient.
- The patient is pregnant or lactating.
- The patient has known HIV positivity.
- The patient has nausea and vomiting or any gastrointestinal disorder that is severe enough to interfere with study drug absorption in the opinion of the investigator.
- The patient has uncontrolled pain.
- The patient has a known hypersensitivity to the study medication or ingredients of the study medication.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Cancer Outreach Assoc. / Outreach Clinical Trial Consortium
Abingdon, Virginia, 24211
Southeastern Gynecologic Oncology, LLC
Atlanta, Georgia, 30342
Augusta Oncology
Augusta, Georgia, 30901
Medical College of Georgia
Augusta, Georgia, 30912
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Hematology Oncology Centers of the Northern Rockies
Billings, Montana, 59101
Saint Joseph Medical Center
Burbank, California, 91505
Iowa Blood and Cancer Care PLC
Cedar Rapids, Iowa, 52402
Charleston Hematology Oncology, PA
Charleston, South Carolina, 29403
Geisinger Medical Center
Danville, Pennsylvania, 17822
Compassionate Cancer Center
Fountain Valley, California, 92708
Frederick Memorial Hospital
Frederick, Maryland, 21701
C. Michael Jones
Germantown, Tennessee, 38138
Ingalls Cancer Research Center
Harvey, Illinois, 60426
Integrated Community Oncology Network
Jacksonville, Florida, 32256
McLeod Cancer and Blood Center
Johnson City, Tennessee, 37604
Wilshire Oncology
La Verne, California, 91750
Montana Cancer Institute
Missoula, Montana, 59802
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, 35661
Compassionate Cancer Center
Riverside, California, 92501
Park Nicollet Institute
Saint Louis Park, Minnesota, 55426
Scripps Cancer Center
San Diego, California, 92123
Summit Cancer Center
Savannah, Georgia, 31405
Sparta Cancer Center
Sparta, New Jersey, 17871
Mount Nittany Medical Center
State College, Pennsylvania, 16803
Cancer Care Associates
Tulsa, Oklahoma, 74136
Washington Cancer Institute
Washington D.C., District of Columbia, 20010
Chester County Hospital
West Chester, Pennsylvania, 19380
Forsyth Regional Cancer Center
Winton, North Carolina, 27103
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Armodafinil Treatment (150 mg/Day) for Patients With Fatigue Associated With Taxane Chemotherapy Alone or in Combination With Other Agents
Evaluate the Safety and Efficacy of Armodafinil Treatment for Patients With Fatigue Associated With Taxane Chemotherapy Alone or in Combination With Other Agents
Read the detailed description
The primary objective of study was to determine whether armodafinil treatment at a dose of 150 mg/day is more effective than placebo treatment in reducing fatigue in patients receiving taxane chemotherapy alone or in combination with other agents by comparing the change from Screening cycle to treatment cycle (cycle 2) in the patient's average daily rating of their worst fatigue severity during the past 24 hours. In addition, the change in the percentage of days with severe fatigue and the mean Brief Fatigue Inventory scores were to be recorded.
- Conditions
- Fatigue, Chemotherapy Side Effects
- Being tested
- Armodafinil 150 mg/day, Placebo,
- Keywords
- Cancer, Fatigue, Taxanes
- Medical subject headings
- Fatigue, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Armodafinil 150 mg/dayDrug
- 150 mg/day armodafinil
- concurrent with one cycle of taxane chemotherapy alone or in combination with other agents
- patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents
Placebo,Drug
- placebo
- concurrent with one cycle of taxane chemotherapy alone or in combination with other agents
- patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents
| Study group | Role | What they receive |
|---|---|---|
| Patient responses to 150 mg/day armodafinil | Active comparator | * 150 mg/day armodafinil
* taxane chemotherapy treatment alone or in combination with other agents Receives: Drug: Armodafinil 150 mg/day |
| Patient responses to placebo | Placebo comparator | * placebo
* taxane chemotherapy treatment alone or in combination with other agents Receives: Drug: Placebo, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Over Time in the Patient's Daily Ratings of Their Worst Fatigue Severity (as Assessed for the Past 24 Hours), Obtained From the Patient's Responses on the Brief Fatigue Inventory (BFI) Questionnaire
Brief Fatigue Inventory (BFI) measures fatigue severity and impact on function on 11-point scale (0-10). Primary outcome measure is average daily rating of BFI question 3: worst level of fatigue over past 24-hours. 0 = no fatigue, 10 = worst imaginable. Study was terminated after only a few patients enrolled and therefore efficacy results were not analyzed and are not reported. Maximum response (most fatigue) would score 10 and minimum response (least fatigue) would score 0. Change was measured from Baseline (cycle 1) to cycle 2. Changes based on matching baseline period with cycle 2 period.
Measured: Recorded once daily by the Patient, for up to 8 weeks total (Screening and Double-Blind)
Secondary outcomes (2)
Percentage of Days With Severe Fatigue, From Patient Responses to the Brief Fatigue Inventory (BFI) Assessment Questionnaire
The Brief Fatigue Inventory (BFI) measures severity of fatigue and impact of fatigue on daily functioning in past 24 hours. It is a 9-item questionnaire that uses an 11-point scale (0-10) to assess severity. 0 represents no fatigue, 10 represents as bad as you can imagine. The percentage of days with severe fatigue as assessed by the BFI was to be assessed. Study was terminated as a result of a business decision after only a few patients were enrolled and therefore efficacy results were not analyzed and are not reported.
Measured: Duration of up to 8 weeks total (Screening and Double-Blind)
Change in the Brief Fatigue Inventory (BFI) Global Score
The Brief Fatigue Inventory (BFI) measures severity of fatigue and impact of fatigue on daily functioning in past 24 hours. It is a 9-item questionnaire that uses an 11-point scale (0-10) to assess severity. Question 3 asks for worst level of fatigue during past 24-hours. 0 represents no fatigue, 10 represents as bad as you can imagine. The global score (0 to 90) determined by adding each item was to be assessed. Study was terminated as a result of a business decision after only a few patients were enrolled and therefore efficacy results were not analyzed and are not reported.
Measured: Duration of up to 8 weeks total (Screening and Double-Blind)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionOct 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FatigueStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sponsor's Medical Expert, Study director, Cephalon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825227
- Sponsor's protocol ID
- C10953/2036/ON/US
- Status last verified
- Oct 2017
- First submitted
- 15 Jan 2009
- Last updated
- 17 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Armodafinil Treatment (150 mg/Day) for Patients With Fatigue Associated With Taxane Chemotherapy Alone or in Combination With Other Agents
- ClinicalTrials.gov ID
- NCT00825227
- Acronym / sponsor ID
- C10953/2036/ON/US
- Conditions
- Fatigue, Chemotherapy Side Effects
- Keywords
- Cancer, Fatigue, Taxanes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 19 Jan 2009 (estimated)
- Results
- Posted 13 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the Safety and Efficacy of Armodafinil Treatment for Patients With Fatigue Associated With Taxane Chemotherapy Alone or in Combination With Other Agents
Detailed description
The primary objective of study was to determine whether armodafinil treatment at a dose of 150 mg/day is more effective than placebo treatment in reducing fatigue in patients receiving taxane chemotherapy alone or in combination with other agents by comparing the change from Screening cycle to treatment cycle (cycle 2) in the patient's average daily rating of their worst fatigue severity during the past 24 hours. In addition, the change in the percentage of days with severe fatigue and the mean Brief Fatigue Inventory scores were to be recorded.
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 |
|---|---|---|
| Patient responses to 150 mg/day armodafinil | Active comparator | Drug: Armodafinil 150 mg/day* 150 mg/day armodafinil * taxane chemotherapy treatment alone or in combination with other agents |
| Patient responses to placebo | Placebo comparator | Drug: Placebo,* placebo * taxane chemotherapy treatment alone or in combination with other agents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The patient has cancer and is receiving, or is scheduled to receive, taxane chemotherapy (paclitaxel, docetaxel, or albumin-bound paclitaxel), either alone or in combination with other agents.
- The patient experiences an average score of 6 or greater for the daily worst fatigue severity assessment during screening.
- The patient has a life expectancy of at least 6 months.
- The patient is able to use the wrist actigraphy device or provide written documentation during the screening period.
- The patient has stable hemoglobin (≥10 g/dL) throughout the screening period.
Key exclusion criteria (12 listed)
- The patient has any untreated reversible medical condition which may cause fatigue (e.g., metabolic disturbance, infection, endocrine abnormalities).
- The patient has received concurrent stimulant medication (e.g., dextroamphetamine or methylphenidate) during the screening period or double-blind treatment period.
- The patient has received concurrent modafinil during the screening period or double-blind treatment period.
- The patient has any delay in chemotherapy treatment such that the screening period extends beyond 6 weeks.
- The patient has known central nervous system (CNS) involvement by metastatic cancer.
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 |
|---|---|---|
| Armodafinil 150 mg/day* 150 mg/day armodafinil * concurrent with one cycle of taxane chemotherapy alone or in combination with other agents * patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents | Drug | Patient responses to 150 mg/day armodafinil |
| Placebo,* placebo * concurrent with one cycle of taxane chemotherapy alone or in combination with other agents * patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents | Drug | Patient responses to placebo |
Primary outcome
Change Over Time in the Patient's Daily Ratings of Their Worst Fatigue Severity (as Assessed for the Past 24 Hours), Obtained From the Patient's Responses on the Brief Fatigue Inventory (BFI) Questionnaire
Time frame: Recorded once daily by the Patient, for up to 8 weeks total (Screening and Double-Blind)
Brief Fatigue Inventory (BFI) measures fatigue severity and impact on function on 11-point scale (0-10). Primary outcome measure is average daily rating of BFI question 3: worst level of fatigue over past 24-hours. 0 = no fatigue, 10 = worst imaginable. Study was terminated after only a few patients enrolled and therefore efficacy results were not analyzed and are not reported. Maximum response (most fatigue) would score 10 and minimum response (least fatigue) would score 0. Change was measured from Baseline (cycle 1) to cycle 2. Changes based on matching baseline period with cycle 2 period.
2 secondary outcomes
Percentage of Days With Severe Fatigue, From Patient Responses to the Brief Fatigue Inventory (BFI) Assessment Questionnaire
Time frame: Duration of up to 8 weeks total (Screening and Double-Blind)
Change in the Brief Fatigue Inventory (BFI) Global Score
Time frame: Duration of up to 8 weeks total (Screening and Double-Blind)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Sponsor's Medical Expert study director
Cephalon
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Armodafinil 150 mg/day in people with Fatigue and Chemotherapy Side Effects, run by Cephalon at 29 sites in United States.
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 10 inclusion and 12 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: stopped early, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change Over Time in the Patient's Daily Ratings of Their Worst Fatigue Severity (as Assessed for the Past 24 Hours), Obtained From the Patient's Responses on the Brief Fatigue Inventory (BFI) Questionnaire (time frame: Recorded once daily by the Patient, for up to 8 weeks total (Screening and Double-Blind)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2017.