Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Joseph Roscoe, University of Rochester Identifier:
First received: December 9, 2009
Last updated: November 6, 2014
Last verified: November 2014

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.

Condition Intervention Phase
Breast Cancer
Drug: armodafinil
Drug: Placebo Comparator
Behavioral: CBT-I
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy

Resource links provided by NLM:

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • To determine if one or more of the intervention strategies (i.e., CBT-I, armodafinil, or both), when compared to a placebo only group, reduce insomnia in breast cancer patients following the conclusion of chemotherapy. [ Time Frame: Severity of insomnia will be assessed by the total score of the Severity Index (ISI) which will be completed every Friday during weeks 3-11 of the study and again during weeks 23 and 24. ] [ Designated as safety issue: No ]
    The primary analysis will use longitudinal models with treatment condition, time, and time by treatment condition as predictors and insomnia severity as the dependent variable.

Secondary Outcome Measures:
  • All three intervention strategies, as compared to the placebo only group, will reduce fatigue in patients, where the largest effects will occur with the two conditions that utilize armodafinil. [ Time Frame: Fatigue will be assessed by the total score of the revised Brief Fatigue Inventory (BFI) which will be completed every Friday during weeks 3-11 of the study and again during weeks 23 and 24. ] [ Designated as safety issue: No ]
    The same modeling strategies as in Hypothesis 1 with the dependent variable replaced by fatigue (as assessed by the BFI total score) will be used. The trend in each group will be assessed by testing the sign of the coefficient of the time variable. Group by group comparisons using appropriate linear contrasts will be used to check if the largest effects occur with two conditions that utilize armodafinil.

Estimated Enrollment: 226
Study Start Date: February 2008
Estimated Study Completion Date: May 2015
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo only
Drug: Placebo Comparator
Placebo for 47 days
Experimental: 2
Armodafinil only
Drug: armodafinil
Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
Experimental: 3
CBT-I and placebo
Drug: Placebo Comparator
Placebo for 47 days
Behavioral: CBT-I
Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)
Experimental: 4
CBT-I + Armodafinil
Drug: armodafinil
Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
Behavioral: CBT-I
Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

Detailed Description:

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 and fatigue and in improving QOL in cancer survivors. Assessments will be made by diary and by questionnaires before, during, two weeks following, and three months 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 assessments i.e., ESS/KSS, ISI, BFI, FACIT, PHQ-9, GODIN, and Medical Symptoms every Friday during weeks 3-11 of the study and again during weeks 23 and 24. In addition, the IDS will be completed on Fridays during weeks 9, 11, and 24 and patients will complete the PSQI, medication log, and feedback questionnaire on Fridays during weeks 11, and 24. 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. Study participants will also be required to maintain a daily sleep diary for the initial 11 weeks of the study (i.e., baseline, intervention, and post period) and for two weeks at follow-up (Weeks 23 and 24).


Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01091974

United States, New York
University of Rochester James P. Wilmot Cancer Center
Rochester, New York, United States, 14642
United States, Pennsylvania
Behavioral Sleep Medicine Program, Department of Psychiatry, University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Rochester
Principal Investigator: Joseph A Roscoe, PhD University of Rochester
  More Information

No publications provided by University of Rochester

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Joseph Roscoe, Research Associate Professor, University of Rochester Identifier: NCT01091974     History of Changes
Other Study ID Numbers: UCCS07090, 1R01CA126968-01A1
Study First Received: December 9, 2009
Last Updated: November 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Breast cancer

Additional relevant MeSH terms:
Signs and Symptoms
Central Nervous System Agents
Central Nervous System Stimulants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Wakefulness-Promoting Agents processed this record on March 03, 2015