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Management of Insomnia in Breast Cancer Patients

This study is currently recruiting participants.
Verified November 2012 by Stanford University
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01011218
First received: November 9, 2009
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

Primary Objective:

  1. To provide preliminary data on the effects of armodafinil and Brief Behavioral Therapy for Insomnia (BBT-I) (alone or in combination) on insomnia in breast cancer patients receiving chemotherapy.

Secondary Objectives:

  1. To provide preliminary data on the influence of armodafinil and BBT-I (alone or in combination) on cancer-related fatigue (CRF) in breast cancer patients receiving chemotherapy.
  2. To provide preliminary data on the influence of armodafinil and BBT-I (alone or in combination) on QOL in breast cancer patients receiving chemotherapy.
  3. To provide preliminary data on influence of armodafinil and BBT-I (alone or in combination) on endocrine and inflammatory physiological markers (measured by cortisol and inflammatory cytokines markers)

Condition Intervention Phase
Insomnia
Fatigue
 Drug: Armodafinil
Behavioral: Brief Behavioral Intervention for Insomnia
Drug: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Insomnia Severity Index [ Time Frame: pre, post, 1 month, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) [ Time Frame: pre, post, 1 month and 6 months ] [ Designated as safety issue: No ]
  • Brief Fatigue Inventory [ Time Frame: pre, post, at 1 month and 6 months ] [ Designated as safety issue: No ]
  • Physiological Markers (Saliva and Blood) [ Time Frame: pre, post, 1 Month and 6 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: January 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral Behavioral: Brief Behavioral Intervention for Insomnia
2 sessions in person and additional brief sessions over the phone
Other Name: BBT-I
Experimental: Drug Drug: Armodafinil
150 mg once a day
Other Name: Nuvigil
Experimental: Drug + Behavioral Drug: Armodafinil
150 mg once a day
Other Name: Nuvigil
Behavioral: Brief Behavioral Intervention for Insomnia
2 sessions in person and additional brief sessions over the phone
Other Name: BBT-I
Placebo Comparator: Placebo Pill Drug: Placebo
Placebo pill
Other Name: Simulated medical intervention

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011218

Contacts
Contact: Oxana Palesh, PhD, MPH 650-725-7011 opalesh@stanford.edu
Contact: Cancer Clinical Trials Office 650-498-7061 ccto-office@stanford.edu

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Oxana Palesh, PhD, MPH     650-725-7011     opalesh@stanford.edu    
Principal Investigator: Oxana Palesh, PhD, MPH            
Sub-Investigator: Melinda Telli, MD            
Sub-Investigator: David Spiegel, MD            
Sub-Investigator: Robert Carlson, MD            
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Oxana Palesh, PhD, MPH Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01011218     History of Changes
Other Study ID Numbers: BRS0008, K07CA132916-01A1, 25740
Study First Received: November 9, 2009
Last Updated: November 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
quality of life

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Sleep Initiation and Maintenance Disorders
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
 Nervous System Diseases
Mental Disorders
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 23, 2013