Clinical trial NCT00902330: Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer
Official title: Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-15
Enrollment: 161
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
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
timeFrame: Up to 2 weeks afer completion of study treatment, for up to 8 months
Secondary outcomes:
measure: To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
timeFrame: up to 2 weeks after completion of study treatment, for up to 8 months
measure: 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).
timeFrame: Baseline
measure: Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).
timeFrame: Baseline
measure: Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline
timeFrame: Baseline
measure: Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy
timeFrame: Baseline
measure: Relationships Among Quality of Life Scores - Means at Baseline
timeFrame: Baseline
measure: Relationships Among Quality of Life Scores - Correlations at Baseline
timeFrame: Baseline
measure: Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).
timeFrame: Midpoint Chemotherapy, up to 4 months
measure: Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy
timeFrame: Midpoint Chemotherapy, up to 4 months
measure: Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy
timeFrame: Midpoint Chemotherapy, up to 4 months
measure: Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy
timeFrame: Midpoint Chemotherapy, up to 4 months
measure: Relationships Among Quality of Life Scores - Means at Midpoint Chemotherapy
timeFrame: Midpoint Chemotherapy, up to 4 months
measure: Relationships Among Quality of Life Scores - Correlations at Midpoint Chemotherapy
timeFrame: Midpoint Chemotherapy, up to 4 months
measure: Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).
timeFrame: Up to 2 weeks after completion of study treatment, for up to 8 months
measure: Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment
timeFrame: Up to 2 weeks afer completion of study treatment, for up to 8 months
measure: Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy
timeFrame: Up to 2 weeks afer completion of study treatment, for up to 8 months
measure: Relationships Among Symptom Scores - Correlations at End of Chemotherapy
timeFrame: Up to 2 weeks afer completion of study treatment, for up to 8 months
measure: Effects of Treatment on Quality of Life - Means at End of Treatment
timeFrame: up to 2 weeks after completion of study treatment, for up to 8 months
measure: Relationships Among Quality of Life Scores - Correlations at End of Chemotherapy
timeFrame: Up to 2 weeks afer completion of study treatment, for up to 8 months
Other outcomes:
Locations:
Study officials:
affiliation: Massey Cancer Center
name: Deborah McGuire, PhD,RN,FAAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.