Management of Insomnia in Breast Cancer Patients
This study is ongoing, but not recruiting participants.
Sponsor:
Stanford University
ClinicalTrials.gov Identifier:
NCT01011218
First Posted: November 11, 2009
Last Update Posted: June 24, 2016
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stanford University
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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 (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
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
Information from the National Library of Medicine
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| 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
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
| 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 ( U.S. NIH Grant/Contract ) 25740 ( Other Identifier: University of Rochester - old protocol ID ) IRB-17323 ( Other Identifier: Stanford IRB ) |
| First Submitted: | November 9, 2009 |
| 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 |