Management of Insomnia in Breast Cancer Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Insomnia, Fatigue

In brief

To provide preliminary data on the effects of brief behavioral therapy for insomnia (BBT-I) on insomnia in breast cancer patients expecting to receive cancer treatment (unspecified). Participants will be randomized into 4 groups: * Arm 1: Brief Behavioral Treatment of Insomnia (BBT-I) + Armodafinil 150 mg/day. * Arm 2: Behavioral therapy for insomnia (CBT-I) + Armodafinil 150 mg/day. * Arm 3: Brief Behavioral Treatment of Insomnia (BBT-I) without pharmaceutical intervention. * Arm 4: Behavioral therapy for insomnia (CBT-I) without pharmaceutical intervention.

Key facts

Study ID

NCT01011218

Run by

Stanford University

People needed

70

Starts

2011-01-01

Expected to finish

2016-07-01

Last updated by the study team

2018-11-29

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Be scheduled for cancer treatment with chemotherapy or biologics (prior chemotherapy and/or diagnosis of metastatic breast are allowed)
• Have at least 6 weeks of treatment remaining
• ≥ 21 years old
• Able to understand written and spoken English
• Able to swallow medication (until amendment omitting armodafinil treatment)
• Score of 3+ on the Sleep Disruption Evaluation form, OR a score of 8+ on Insomnia Severity Index (ISI)

You may not qualify if…

• Prior treatment with armodafinil or modafinil (until amendment omitting armodafinil treatment)
• Prior treatment with psycho-stimulant medication within the past 28 days (until amendment omitting armodafinil treatment)
• Prior treatment with antiseizure medications (until amendment omitting armodafinil treatment)
• Has continuously taken sleep medication daily for the last 28 days (until amendment omitting armodafinil treatment)
• History (self-reported) of unstable medical or psychiatric illness (within the last 5 years)
• History of uncontrolled, cardiac disease, hypertension, severe headaches, glaucoma, or seizures (until amendment omitting armodafinil treatment)
• Pregnant or nursing
• History of substance abuse or meet criteria for current alcohol abuse or dependence
• History (self-reported) of chronic, preexisting insomnia, sleep apnea, or restless leg syndrome (RLS)
• Severe hepatic impairment (until amendment omitting armodafinil treatment)

Where it is running

• Stanford University — Stanford, California, United States

Full record on ClinicalTrials.gov

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