Management of Insomnia in Breast Cancer Patients

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Armodafinil; Modafinil

Criteria

INCLUSION CRITERIA

• 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)

EXCLUSION CRITERIA

• 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)