Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer

NCT ID: NCT00902330

Last Updated: 2015-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2014-05-31

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 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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

energy-based therapy

Intervention Type: PROCEDURE

Given once a day for 18 weeks

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.

Group Type: SHAM_COMPARATOR

sham intervention

Intervention Type: PROCEDURE

Given once a day for 18 weeks

Interventions

energy-based therapy

Given once a day for 18 weeks

Intervention Type: PROCEDURE

sham intervention

Given once a day for 18 weeks

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deborah McGuire, PhD,RN,FAAN

Role: PRINCIPAL_INVESTIGATOR

Massey Cancer Center

References

Lyon D, Kelly D, Walter J, Bear H, Thacker L, Elswick RK. Randomized sham controlled trial of cranial microcurrent stimulation for symptoms of depression, anxiety, pain, fatigue and sleep disturbances in women receiving chemotherapy for early-stage breast cancer. Springerplus. 2015 Jul 23;4:369. doi: 10.1186/s40064-015-1151-z. eCollection 2015.

Reference Type: DERIVED

PMID: 26435889 (View on PubMed)

Other Identifiers

HM11995

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000641994

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2011-00234

Identifier Type: REGISTRY

Identifier Source: secondary_id

MCC-11995

Identifier Type: -

Identifier Source: org_study_id