Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy
Information source: University of Rochester
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Insomnia; Fatigue; Breast Cancer
Intervention: armodafinil (Drug); Placebo Comparator (Drug); CBT-I (Behavioral)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: University of Rochester
Official(s) and/or principal investigator(s):
Joseph A Roscoe, PhD, Principal Investigator, Affiliation: University of Rochester
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.
Official title: Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: Change in Insomnia Severity Index From Baseline to Post-intervention
Secondary outcome: Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) .
Treatment Protocol: CBT-I and armodafinil are being studied in a four-arm, randomized,
controlled, clinical trial of 226 cancer survivors with chronic insomnia who are at least
one month post treatment. The seven-week intervention is designed to determine the efficacy
and acceptability of these treatment strategies in reducing insomnia in cancer survivors.
Assessments will be made by questionnaires before, during, and two weeks following the study
intervention. All ancillary treatments, as appropriate for control of symptoms caused by the
cancer or its treatment may be administered as clinically indicated.
Withdrawal of Sleep Medications: All participants, prior to beginning the baseline data
collection phase of the study, must have withdrawn from all sleep medications, including:
prescription, over-the-counter, CAM and herbal remedies for at least one week prior to
beginning the study.
CBT-I (Arms 3 & 4): CBT-I will be provided on an individual basis to all patients in study
Arms 3 & 4 by a licensed clinical psychologist trained in CBT-I by Dr. Perlis. Subjects in
these two study arms will receive 7 weeks of CBT-I, using a structured research grade
protocol developed at the UR-SNRL. This manualized intervention, which exists as a published
text: Perlis et al., 2005, includes four essential components: Sleep Restriction Therapy,
Stimulus Control Instruction, Sleep Hygiene Guidelines, and a session of cognitive therapy.
Data Collection: Patients will complete the Insomnia Severity (ISI) at the time of consent
and every Friday during weeks 3-11 of the study. A follow-up call by study personnel will
be made to each participant not currently receiving CBT-I on each of these Fridays to
promote compliance, prompt completion, assess potential side effects of study medication,
and answer patient questions.
Minimum age: 21 Years.
Maximum age: 75 Years.
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
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
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
3. Have a history of seizures or severe headaches, or uncontrolled cardiac disease or
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.
Locations and Contacts
University of Rochester James P. Wilmot Cancer Center, Rochester, New York 14642, United States
Behavioral Sleep Medicine Program, Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
Starting date: February 2008
Last updated: March 11, 2015