Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy
Condition: Insomnia; Fatigue; Breast Cancer
MeSH terms: Sleep Initiation and Maintenance Disorders; Fatigue
Intervention: armodafinil; Placebo Comparator; CBT-I
Intervention description: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg); Placebo for 47 days; Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)
Intervention MeSH terms: Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 138.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Insomnia; Fatigue; QOL; CBT; Breast cancer; Survivors; Chemotherapy

Summary:

      This is a four-arm, randomized, controlled, clinical trial examining the efficacy of of
      cognitive behavioral therapy (CBT)-I and armodafinil in reducing insomnia in 226 female
      breast cancer patients who report sleep disturbances following completion of chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have a diagnosis of cancer.

          2. Be able to understand written and spoken English

          3. Be able to swallow medication

          4. Have preferred sleep phase between 7:30 pm and 11:00 am

          5. Be willing to discontinue any medications/OTCs/Herbals for sleep for the 11-week study
             period

          6. Be presumed to be in a state of cancer remission; use of tamoxifen, an aromatase
             inhibitor, and/or Herceptin is permitted

          7. Self-report problems with insomnia for at least three months and that the insomnia
             began or got worse with the onset of cancer or treatment

          8. Have completed chemotherapy and or radiation not less than one month ago. Note: Both
             types of treatment must be completed at least one month ago if patient receives
             chemotherapy and radiation therapy and there is no outer limit to how long ago
             treatments were completed.)

          9. Report insomnia on the SDS-CL at a frequency of at least 3 days a week

        Exclusion Criteria:

          1. Have ever taken modafinil or had CBT-I therapy. CBT-I therapy for the sake of this
             protocol will be defined as any cognitive behavioral-based treatment for insomnia that
             includes a sleep restriction component.

          2. Have an unstable medical or psychiatric illness (Axis I-current or within the last 5
             years)

          3. Have a history of seizures or severe headaches, or uncontrolled cardiac disease or
             hypertension

          4. Be presently taking an anticoagulant or a corticosteroid

          5. Have taken amphetamines (e.g., methylphenidate, pemoline [Cylert®] or similar psycho
             stimulants) within the past 30 days

          6. Be currently pregnant or nursing

          7. Have a history of substance abuse, or meet criteria for current alcohol abuse or
             dependence as assessed by a CAGE test score >=2 or an Alcohol Use Disorders
             Identification Test (AUDIT) score >=13

          8. Have surgery planned within the study period

          9. Have have ever been diagnosed with sleep apnea or have sleep apnea as indicated by
             endorsing either question 11 (I wake up choking or gasping for air) or question 12 (My
             bed partner has noticed that I seem to stop breathing) on the Sleep Disorders Symptom
             Check at the "Often" or "Frequently" level.