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Management of Insomnia in Breast Cancer Patients

This study is currently recruiting participants.
Verified May 2013 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: May 28, 2013
Last verified: May 2013
History of Changes

November 9, 2009
May 28, 2013
January 2011
November 2013   (final data collection date for primary outcome measure)
Insomnia Severity Index [ Time Frame: pre, post, 1 month, 6 months ] [ Designated as safety issue: No ]
Insomnia Severity Index [ Time Frame: pre, post, 3 months, 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01011218 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) [ Time Frame: pre, post, 3 months and 6 months ] [ Designated as safety issue: No ]
  • Brief Fatigue Inventory [ Time Frame: pre, post, at 3 and 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Management of Insomnia in Breast Cancer Patients
Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study

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)
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Insomnia
  • Fatigue
  • 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
  • Drug: Placebo
    Placebo pill
    Other Name: Simulated medical intervention
  • Experimental: Behavioral
    Intervention: Behavioral: Brief Behavioral Intervention for Insomnia
  • Experimental: Drug
    Intervention: Drug: Armodafinil
  • Experimental: Drug + Behavioral
    Interventions:
    • Drug: Armodafinil
    • Behavioral: Brief Behavioral Intervention for Insomnia
  • Placebo Comparator: Placebo Pill
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
64
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Female
21 Years and older
No
Contact: Oxana Palesh, PhD, MPH 650-725-7011 opalesh@stanford.edu
Contact: Cancer Clinical Trials Office 650-498-7061 ccto-office@stanford.edu
United States
 
NCT01011218
BRS0008, K07CA132916-01A1, 25740
Yes
Stanford University
Stanford University
National Cancer Institute (NCI)
Principal Investigator: Oxana Palesh, PhD, MPH Stanford University
Stanford University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP