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

May 14, 2009
December 17, 2013
April 2009
May 2013   (final data collection date for primary outcome measure)
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).
Changes in symptoms of depression, anxiety, fatigue, pain, and sleep disturbances over time [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00902330 on ClinicalTrials.gov Archive Site
  • 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.
  • Relationships among biomarkers, symptoms, and quality of life [ Designated as safety issue: No ]
  • Clustering of symptoms [ Designated as safety issue: No ]
  • Effects of treatment on quality of life [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer
Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Anxiety Disorder
  • Breast Cancer
  • Depression
  • Fatigue
  • Pain
  • Sleep Disorders
  • Procedure: energy-based therapy
    Given once a day for 18 weeks
  • Procedure: sham intervention
    Given once a day for 18 weeks
  • 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.
    Intervention: Procedure: energy-based therapy
  • 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.
    Intervention: Procedure: sham intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
169
October 2014
May 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00902330
MCC-11995, HM11995, CDR0000641994, NCI-2011-00234
Yes
Virginia Commonwealth University
Virginia Commonwealth University
National Cancer Institute (NCI)
Principal Investigator: Debra E. Lyon, MD Massey Cancer Center
Virginia Commonwealth University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP