Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer

Virginia Commonwealth University (VCU)

Status and phase: Completed; Phase 3

Conditions: Sleep Disorders; Breast Cancer; Anxiety Disorder; Depression; Fatigue; Pain

Treatments: Procedure: sham intervention; Procedure: energy-based therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00902330

MCC-11995

CDR0000641994 (Registry Identifier)

HM11995 (Other Identifier)

NCI-2011-00234 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 161 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

161 participants in 2 patient groups

Arm I (cranial microcurrent electrical stimulation [CES])

Experimental group

Description:

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.

Treatment:

Procedure: energy-based therapy

Arm II (sham CES)

Sham Comparator group

Description:

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.

Treatment:

Procedure: sham intervention