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:

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:

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.
To provide preliminary data on the influence of armodafinil and BBT-I (alone or in combination) on QOL in breast cancer patients receiving chemotherapy.
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 Intervention Model: Single Group Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment
Official Title:	Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Fatigue

Drug Information available for: Modafinil Armodafinil

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


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)
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

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 ( US NIH Grant/Contract Award Number ) 25740 ( Other Identifier: University of Rochester - old protocol ID ) IRB-17323 ( Other Identifier: Stanford IRB )
Study First Received:	November 9, 2009
Last Updated:	June 23, 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

ClinicalTrials.gov processed this record on June 23, 2017

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