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Management of Insomnia in Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01011218
Recruitment Status : Completed
First Posted : November 11, 2009
Results First Posted : October 9, 2018
Last Update Posted : November 29, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Oxana Palesh, Stanford University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Insomnia Fatigue Behavioral: BBT-I Behavioral: Control Drug: Armodafinil Phase 2

Detailed Description:

The purpose of this study is to test the efficacy of Brief Behavioral Treatment of Insomnia (BBT-I) in the treatment of insomnia in humans.

Insomnia is an extraordinarily common problem for cancer patients that is often associated with diminished social and vocational functioning and QOL. It is also likely that insomnia exacerbates other cancer-related symptoms (eg, fatigue, nausea, depressive mood, pain and/or reduced pain tolerance) and thus gives rise to the possibility of additive or multiplicative interactions. It is possible that untreated insomnia in the context of cancer therapy may lead to chronic forms of insomnia in cancer survivors which, in turn, independently confers risk for increased psychiatric and medical morbidity.

Thus, insomnia, by itself, is a significant problem that requires better understanding in order that its high prevalence can be reduced.

Developing interventions that might prevent onset of insomnia in breast cancer patients is vital.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study
Study Start Date : January 2011
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue
Drug Information available for: Armodafinil

Arms and Interventions
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Arm Intervention/treatment
Experimental: BBT-I + Armodafinil

Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.

Armodafinil 150 mg/day by mouth.

 Behavioral: BBT-I
Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
Other Name: Brief Behavioral Intervention for Insomnia

Drug: Armodafinil
150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
Other Name: Nuvigil
Experimental: Behavioral placebo + Armodafinil

Control behavioral intervention is a sleep hygiene handout completed by participant.

Armodafinil 150 mg/day by mouth.

 Behavioral: Control
Control behavioral intervention is a sleep hygiene handout completed by participant.
Other Name: Behavioral placebo

Drug: Armodafinil
150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
Other Name: Nuvigil
Sham Comparator: BBT-I without Armodafinil

Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.

No pharmaceutical intervention.

 Behavioral: BBT-I
Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
Other Name: Brief Behavioral Intervention for Insomnia
Placebo Comparator: Behavioral placebo without Armodafinil

Control behavioral intervention is a sleep hygiene handout completed by participant.

No pharmaceutical intervention.

 Behavioral: Control
Control behavioral intervention is a sleep hygiene handout completed by participant.
Other Name: Behavioral placebo


Outcome Measures
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Primary Outcome Measures :
  1. Insomnia Severity Index (ISI) [ Time Frame: up to 32 Weeks ]

    Insomnia Severity Index (ISI) survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows.

    • 0 to 7 No clinically significant insomnia
    • 8 to14 Subthreshold insomnia
    • 15 to 21 Clinical insomnia (moderate severity)
    • 22 to 28 Clinical insomnia (severe)

    ISI survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean ISI score with standard deviation.



Secondary Outcome Measures :
  1. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) [ Time Frame: up to 32 Weeks ]

    The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) survey questionnaire is a 13-question subset of the 41-question Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire, with each question having 5 possible answers (not at all; a little bit; somewhat; quite a bit; very much), scored as 0, 1, 2, 3, or 4, respectively. The full range of FACIT-Fatigue scores is from 0 to 52. Higher scores are considered good, better, or healthy, and increasingly lower scores are considered to indicate greater fatigue.

    The FACIT-Fatigue survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean with standard deviation.



Other Outcome Measures:
  1. The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) [ Time Frame: up to 32 Weeks ]

    The full Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) survey questionnaire is a 41-question survey, with each question having 5 possible answers (not at all; a little bit; somewhat; quite a bit; very much), scored as 0, 1, 2, 3, or 4, respectively. The full range of scores is from 0 to 164. Higher scores are considered good, better, or healthy, and increasingly lower scores are considered to indicate greater fatigue.

    The FACIT-F survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean with standard deviation.


  2. Brief Fatigue Inventory (BFI) [ Time Frame: up to 32 Weeks ]

    The Brief Fatigue Inventory (BFI) survey questionnaire is a 9-question survey, with each question having 11 possible answers ("No fatigue" to "As bad as you can imagine"), scored from 0 to 10, with each patient's overall BFI score being the mean of the values from each question (overall range 0 to 10). Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater fatigue.

    The BFI survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean of the overall BFI scores with standard deviation.



Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Females with breast cancer
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01011218


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Oxana RG Palesh, PhD, MPH Stanford University
More Information
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Responsible Party: Oxana Palesh, Assistant Professor of Psychiatry and Behavioral Sciences, Stanford University
ClinicalTrials.gov Identifier: NCT01011218    
Other Study ID Numbers: IRB-17323
K07CA132916-01A1 ( U.S. NIH Grant/Contract )
25740 ( Other Identifier: University of Rochester - old protocol ID )
BRS0008 ( Other Identifier: OnCore )
First Posted: November 11, 2009    Key Record Dates
Results First Posted: October 9, 2018
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Modafinil
 Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action