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

Completed · Phase 2 · Has a placebo group

Conditions studied: Insomnia, Fatigue, Breast Cancer

In brief

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.

Key facts

Study ID

NCT01091974

Run by

University of Rochester

People needed

138

Starts

2008-02-01

Expected to finish

2013-04-01

Last updated by the study team

2017-02-09

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis of cancer.
• Be able to understand written and spoken English
• Be able to swallow medication
• Have preferred sleep phase between 7:30 pm and 11:00 am
• Be willing to discontinue any medications/OTCs/Herbals for sleep for the 11-week study period
• Be presumed to be in a state of cancer remission; use of tamoxifen, an aromatase inhibitor, and/or Herceptin is permitted
• 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
• 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.)
• Report insomnia on the SDS-CL at a frequency of at least 3 days a week

You may not qualify if…

• 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.
• Have an unstable medical or psychiatric illness (Axis I-current or within the last 5 years)
• Have a history of seizures or severe headaches, or uncontrolled cardiac disease or hypertension
• Be presently taking an anticoagulant or a corticosteroid
• Have taken amphetamines (e.g., methylphenidate, pemoline [Cylert®] or similar psycho stimulants) within the past 30 days
• Be currently pregnant or nursing
• 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
• Have surgery planned within the study period
• 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.

Where it is running

• University of Rochester James P. Wilmot Cancer Center — Rochester, New York, United States
• Behavioral Sleep Medicine Program, Department of Psychiatry, University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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