Safety and Efficacy of Armodafinil for Fatigue Associated With Taxanes Alone or in Combination With Other Agents
Condition: Fatigue; Chemotherapy Side Effects
MeSH terms: Fatigue
Intervention: Armodafinil 150 mg/day; Placebo,
Intervention description: 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
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
Intervention MeSH terms: Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; Fatigue; Taxanes

Summary:

      Evaluate the Safety and Efficacy of Armodafinil Treatment for Patients With Fatigue
      Associated With Taxane Chemotherapy Alone or in Combination With Other Agents
    

Eligibility criteria:

        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.