Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer

NCT00902330 | Completed Phase 3 Results DMC

• 4 other identifiers: MCC-11995HM11995CDR0000641994NCI-2011-00234
• Study Type: interventional
• Target: 161
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

depression; anxiety disorder; fatigue; pain; sleep disorders; stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer

Outcome Measures

Primary Outcomes (1)

• 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

  Using Hospital Anxiety and Depression Scale (HADS) a 14 item scale, 7 relate to anxiety, 7 to depression; each item is scored from 0-3, a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. Has 9 questions with 0 (does not interfere) to 10 (completely interferes), the total mean score is the mean of the 9 questions; severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire

  Up to 2 weeks afer completion of study treatment, for up to 8 months

Secondary Outcomes (19)

• To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.

  up to 2 weeks after completion of study treatment, for up to 8 months

• Means and Standard Deviations of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).

  Baseline

• Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).

  Baseline

• Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline

  Baseline

• Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy

  Baseline

Study Arms (2)

Arm I (cranial microcurrent electrical stimulation [CES])

EXPERIMENTAL

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

Arm II (sham CES)

SHAM COMPARATOR

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

Interventions

energy-based therapy PROCEDURE

Given once a day for 18 weeks

Arm I (cranial microcurrent electrical stimulation [CES])

sham intervention PROCEDURE

Given once a day for 18 weeks

Arm II (sham CES)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Cancer Institute (NCI): collaborator

Related Publications (1)

• 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.

  PMID: 26435889 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Breast Neoplasms; Depression; Fatigue; Pain; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Debra Lyon, RN, PhD, FNP
• Organization: Virginia Commonwealth University

delyon@vcu.edu

804-828-7743

Study Officials

• Deborah McGuire, PhD,RN,FAAN

  Massey Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2009
• First Posted: May 15, 2009
• Study Start: April 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2014
• Last Updated: November 23, 2015
• Results First Posted: April 2, 2015

Record last verified: 2015-11