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Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00902330
First received: May 14, 2009
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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 receiving chemotherapy. It is not yet known whether CES is more effective than sham therapy in reducing symptoms caused by chemotherapy in women with breast cancer.

PURPOSE: This randomized phase III trial is studying mild electrical stimulation to see how well it works compared with sham therapy in reducing symptoms caused by chemotherapy in women with stage I, stage II, or stage IIIA breast cancer receiving chemotherapy.


Condition Intervention Phase
Anxiety Disorder
Breast Cancer
Depression
Fatigue
Pain
Sleep Disorders
Procedure: energy-based therapy
Procedure: sham intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Effects of CES as compared to sham CES on symptoms of depression, anxiety, fatigue, pain and sleep disturbances in women receiving adjuvant chemotherapy for early-stage breast cancer [ Time Frame: Up to 2 weeks afer completion of study treatment ] [ Designated as safety issue: No ]
    Measured using the Hospital Anxiety and Depression Scale (HADS), the Brief Pain Inventory (BPI) short-form, the Brief Fatigue Inventory (BFI), and the General Sleep Disturbance Scale (GSDS).


Secondary Outcome Measures:
  • Relationships among biomarkers, symptoms, and quality of life [ Time Frame: up to 2 weeks after completion of study treatment ] [ Designated as safety issue: No ]
    Simple correlations will be computed at each time point for the biomarkers, symptoms (depression, anxiety, fatigue, pain, and sleep disturbances), and QOL.

  • To examine whether the symptoms of depression, anxiety, fatigue, sleep disturbances and pain form a cluster. [ Time Frame: up to 2 weeks after completion of study treatment ] [ Designated as safety issue: No ]
    factor analysis is one of the suggested techniques to discover the underlying structure the symptoms of depression, anxiety, fatigue, pain and sleep disturbances [13]. We will first examine correlations between the symptoms at baseline to determine a general pattern of association. Then, factor analysis will be performed to examine how these five symptoms cluster

  • Effects of treatment on quality of life [ Time Frame: up to 2 weeks after completion of study treatment ] [ Designated as safety issue: No ]
    estimated by examining the changes in QOL by group at three time-points: baseline, approximately mid-point chemotherapy (week 7 or 9) and at two weeks after the final cycle of chemotherapy.


Enrollment: 169
Study Start Date: April 2009
Estimated Study Completion Date: October 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (cranial microcurrent electrical stimulation [CES])
Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.
Procedure: energy-based therapy
Given once a day for 18 weeks
Sham Comparator: Arm II (sham CES)
Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.
Procedure: sham intervention
Given once a day for 18 weeks

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 women with stage I-IIIA breast cancer receiving adjuvant chemotherapy.

Secondary

  • To explore the relationships among selected markers of inflammation (e.g., tumor necrosis factor alpha, interleukin-6, interleukin-1β, and C-reactive protein), symptoms, and quality of life.
  • To examine whether the symptoms of depression, anxiety, fatigue, sleep disturbances, and pain form a cluster.
  • To examine the effects of CES on quality of life.

OUTLINE: Patients are stratified according to chemotherapy schedule (every 2 weeks for 8 courses vs every 3 weeks for 6 courses). Patients are randomized to 1 of 2 treatment arms.

  • Arm I (cranial microcurrent electrical stimulation [CES]): Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.
  • Arm II (sham CES): Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.

Patients complete symptom questionnaires (e.g., the Hospital Anxiety and Depression Scale, the Brief Pain Inventory Short-Form, the Brief Fatigue Inventory, and the General Sleep Disturbance Scale) weekly in weeks 1-18. Patients also complete a quality-of-life questionnaire in weeks 1, 7, and 18.

Blood samples are collected in weeks 1, 7, and 18 and analyzed for cytokines (e.g., tumor necrosis factor alpha, interleukin-6, and interleukin-1β) and C-reactive protein.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00902330

Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Debra E. Lyon, MD Massey Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00902330     History of Changes
Other Study ID Numbers: MCC-11995, HM11995, CDR0000641994, NCI-2011-00234
Study First Received: May 14, 2009
Last Updated: December 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
depression
anxiety disorder
fatigue
pain
sleep disorders
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Anxiety Disorders
Breast Neoplasms
Depression
Depressive Disorder
Disease
Fatigue
Parasomnias
Sleep Disorders
Behavioral Symptoms
Breast Diseases
Mental Disorders
Mood Disorders
Neoplasms
Neoplasms by Site
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Skin Diseases

ClinicalTrials.gov processed this record on November 24, 2014