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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01091974
• Other study ID #: UCCS07090
• Secondary ID: 1R01CA126968-01A
• Status: Completed
• Phase: Phase 2
• First received: December 9, 2009
• Last updated: August 4, 2015
• Start date: February 2008
• Est. completion date: April 2013

Study information

• Verified date: August 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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of Sleep Medications: All participants, prior to beginning the baseline data collection phase of the study, must have withdrawn from all sleep medications, including: prescription, over-the-counter, CAM and herbal remedies for at least one week prior to beginning the study.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Fatigue
• Insomnia

Intervention

Drug:
• armodafinil
Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
• Placebo Comparator
Placebo for 47 days

Behavioral:
• CBT-I
Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)

Locations

Country	Name	City	State
United States	Behavioral Sleep Medicine Program, Department of Psychiatry, University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Rochester James P. Wilmot Cancer Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Insomnia Severity Index From Baseline to Post-intervention	The Insomnia Severity Index (ISI) is a commonly used, 7-item psychometrically validated measure used to rate insomnia with 0-7 = absence of insomnia, 8-14 = subthreshold insomnia symptoms, 15-21 = moderate insomnia, and 22-28 = severe insomnia.	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).	No
Secondary	Fatigue Will be Assessed by the Total Score of the Revised Brief Fatigue Inventory (BFI) .	The revised Brief Fatigue Inventory (BFI) is a 9-item, patient-report instrument with established reliability and validity.	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	No