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Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study


Phase 2/Phase 3
21 Years
N/A
Open (Enrolling)
Female
Insomnia, Fatigue

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Trial Information

Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study


Inclusion Criteria:



- Be scheduled for planned cancer treatment with chemotherapy or biologics, such as
Herceptin (prior chemotherapy and diagnosis of metastatic breast are allowed)

- Have at least 6 weeks of treatment remaining

- Be at least 21 years old

- Be able to swallow medication

- Exhibit onset or worsening of problems falling or staying asleep

Exclusion Criteria:

- Have ever taken armodafinil or modafinil

- Have an unstable medical or psychiatric illness (Axis I - current or within the last
5 years)

- Have a history of or uncontrolled cardiac disease, hypertension, severe headaches,
glaucoma, or seizures

- Have taken a psycho-stimulant medication within the past 28 days

- Be currently pregnant or nursing

- Have a history of substance abuse or meet criteria for current alcohol abuse or
dependence

- Have a self-reported history of chronic, preexisting insomnia, sleep apnea, or RLS
syndrome

- Have taken sleep medication daily for the last 28 days continuously

- Have severe hepatic impairment

- Be taking anti-seizure medications

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Insomnia Severity Index

Outcome Time Frame:

pre, post, 1 month, 6 months

Safety Issue:

No

Principal Investigator

Oxana Palesh, PhD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

BRS0008

NCT ID:

NCT01011218

Start Date:

January 2011

Completion Date:

November 2013

Related Keywords:

  • Insomnia
  • Fatigue
  • quality of life
  • Breast Neoplasms
  • Fatigue
  • Sleep Initiation and Maintenance Disorders

Name

Location

Stanford UniversityStanford, California  94305