Management of Insomnia in Breast Cancer Patients

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Insomnia; Fatigue	Drug: Armodafinil; Behavioral: Brief Behavioral Intervention for Insomnia (BBT-I); Drug: Placebo	Phase 2; Phase 3

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	64 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study
Study Start Date :	January 2011
Estimated Primary Completion Date :	July 2016
Estimated Study Completion Date :	July 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Insomnia Severity Index (ISI) [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) [ Time Frame: 6 months ]
2. Brief Fatigue Inventory [ Time Frame: 6 months ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	21 Years and older (Adult, Senior)
Sexes 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Stanford University
ClinicalTrials.gov Identifier:	NCT01011218 History of Changes
Other Study ID Numbers:	BRS0008; K07CA132916-01A1 ( U.S. NIH Grant/Contract ); 25740 ( Other Identifier: University of Rochester - old protocol ID ); IRB-17323 ( Other Identifier: Stanford IRB )
First Posted:	November 11, 2009
Last Update Posted:	June 24, 2016
Last Verified:	June 2016

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