Overview

This trial is active, not recruiting.

Conditions insomnia, fatigue, breast cancer
Treatments armodafinil, placebo comparator, cbt-i
Phase phase 2
Sponsor University of Rochester
Collaborator National Cancer Institute (NCI)
Start date February 2008
End date May 2014
Trial size 138 participants
Trial identifier NCT01091974, 1R01CA126968-01A1, UCCS07090

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
CBT-I and placebo
placebo comparator
Placebo for 47 days
cbt-i
Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)
(Experimental)
CBT-I + Armodafinil
armodafinil
Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
cbt-i
Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)
(Placebo Comparator)
Placebo only
placebo comparator
Placebo for 47 days
(Experimental)
Armodafinil only
armodafinil
Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)

Primary Outcomes

Measure
Change in Insomnia Severity Index From Baseline to Post-intervention
time frame: ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of consent (pre).

Secondary Outcomes

Measure
Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) .
time frame: ANCOVA was employed with multiple imputation on the post-intervention score (average of the two post-intervention weeks), controlling for the score at the time of

Eligibility Criteria

Male or female participants from 21 years up to 75 years old.

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.

Additional Information

Official title Cognitive Behavioral Therapy +/- Armodafinil for Insomnia and Fatigue Following Chemotherapy
Principal investigator Joseph A Roscoe, PhD
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by University of Rochester.