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Management of Insomnia in Breast Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01011218
First received: November 9, 2009
Last updated: June 23, 2016
Last verified: June 2016
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 (BBT-I)
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:

MedlinePlus related topics: Fatigue
U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Insomnia Severity Index (ISI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Brief Fatigue Inventory [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 64
Study Start Date: January 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brief Behavioral Therapy for Insomnia (BBT-I)
2 Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone
 Behavioral: Brief Behavioral Intervention for Insomnia (BBT-I)
2 sessions in person and additional brief sessions over the phone
Other Name: BBT-I
Experimental: Armodafinil
150 mg once a day
 Drug: Armodafinil
150 mg once a day
Other Name: Nuvigil
Experimental: BBT-I + Armodafinil
2 BBT-I sessions in person and additional brief BBT-I sessions over the phone + 150 mg Armodafinil once a day
 Drug: Armodafinil
150 mg once a day
Other Name: Nuvigil
Behavioral: Brief Behavioral Intervention for Insomnia (BBT-I)
2 sessions in person and additional brief sessions over the phone
Other Name: BBT-I
Placebo Comparator: Placebo
Placebo for Armodafinil
 Drug: Placebo
Placebo pill
Other Name: Simulated medical intervention

  Eligibility
Ages Eligible for Study:   21 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Oxana RG Palesh, PhD, MPH Stanford University
  More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01011218     History of Changes
Other Study ID Numbers: BRS0008  K07CA132916-01A1  25740  IRB-17323 
Study First Received: November 9, 2009
Last Updated: June 23, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
quality of life

Additional relevant MeSH terms:
Fatigue
Sleep Initiation and Maintenance Disorders
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
 Armodafinil
Modafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2016