Status:
COMPLETED
Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anxiety Disorder
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Cranial microcurrent electrical stimulation (CES) is mild electrical current received through electrodes placed on the earlobes. CES may lessen symptoms in women with breast cancer receivin...
Detailed Description
OBJECTIVES: Primary * To compare the effects of cranial microcurrent electrical stimulation (CES) vs sham CES over time on symptoms of depression, anxiety, fatigue, pain, and sleep disturbances in w...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of stage I-IIIA breast cancer
- Scheduled to receive adjuvant chemotherapy
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Pre, peri, or post-menopausal
- ECOG performance status 0-1
- No dementia
- No active psychosis
- No history of seizure disorder
- No implanted electrical device
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy
- No initiation of a medication regimen for depression or other psychiatric condition within the past 30 days
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT00902330
Start Date
April 1 2009
End Date
May 1 2014
Last Update
November 23 2015
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