Safety and Efficacy of Armodafinil for Fatigue Associated With Taxanes Alone or in Combination With Other Agents

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Fatigue, Chemotherapy Side Effects

Intervention / Treatment
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* Drug: Armodafinil 150 mg/day
* Drug: Placebo,


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 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. 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. Key Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patient responses to 150 mg/day armodafinil<br>150 mg/day armodafinil taxane chemotherapy treatment alone or in combination with other agents | Drug: Armodafinil 150 mg/day<br>* 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<br>|
| Placebo Comparator: Patient responses to placebo<br>placebo taxane chemotherapy treatment alone or in combination with other agents | Drug: Placebo,<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Recorded once daily by the Patient, for up to 8 weeks total (Screening and Double-Blind) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Duration of up to 8 weeks total (Screening and Double-Blind) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Fatigue, Taxanes