Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer

Breast Cancer Clinical Trial

Official title:

Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902330
• Other study ID #: MCC-11995
• Secondary ID: HM11995CDR000064
• Status: Completed
• Phase: Phase 3
• First received: May 14, 2009
• Last updated: November 19, 2015
• Start date: April 2009
• Est. completion date: May 2014

Study information

• Verified date: November 2015
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: May 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Breast Cancer
• Breast Neoplasms
• Depression
• Disease
• Fatigue
• Pain
• Parasomnias
• Sleep Disorders

Intervention

Procedure:
• energy-based therapy
Given once a day for 18 weeks
• sham intervention
Given once a day for 18 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.	Examine correlations between the symptoms at baseline to determine a general pattern of association. Factor analysis (a statistical method used to describe variability among observed, correlated variables in terms of a potentially lower number of unobserved variables called factors) was performed to examine how these 5 symptoms cluster. A principal component factor analysis was performed on the correlation matrix for the symptom scores of anxiety, depression, pain, fatigue and sleep disturbance at up to two weeks after completion of study treatment, up to 8 months). For each analysis two factors were retained that explained 74% of the variability for the baseline symptom scores, 79% of the variability of the symptom scores at the midpoint and 78% of the variability in symptom scores at study completion. A varimax rotation was utilized and the factor loadings from the varimax rotation were reported.	up to 2 weeks after completion of study treatment, for up to 8 months	No
Secondary	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).	Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-ß, IL-6, TNF-a, CRP. These are the biomarkers of inflammation.	Baseline	No
Secondary	Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).	Simple correlations will be computed at Baseline for the log transformed biomarker values; IL1-ß, IL-6, TNF-a, CRP. These are the biomarkers of inflammation.	Baseline	No
Secondary	Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline	Measured using Hospital Anxiety and Depression Scale (HADS) a fourteen item scale, 7 relate to anxiety and 7 to depression; each item is scored from 0-3, this means 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 of pain 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. it has 9 questions with 0 (does not interfere) to 10 (completely interferes); 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 scoring system.	Baseline	No
Secondary	Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy	Simple correlations will be computed at Baseline Chemotherapy for symptoms.	Baseline	No
Secondary	Relationships Among Quality of Life Scores - Means at Baseline	Measured using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). A 44-item self-report instrument designed to measure multidimensional quality of life in patient with breast cancer. 0=not at all to 4=very much. Utilized standard questionnaire scoring system. The items are summed to produce a total score 0=not at all to 176=very much. The FACT-B BCA has 10 questions that range from 0 (not at all) to 4 (very much); thus the FACT-B BCA ranges from 0 to 40. Both the FACT-B and FACT-BCA are scored so that high scores indicate higher levels of quality of life.	Baseline	No
Secondary	Relationships Among Quality of Life Scores - Correlations at Baseline	Simple correlations will be computed at Baseline for quality of life scores.	Baseline	No
Secondary	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).	Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-ß, IL-6, TNF-a, CRP. These are the biomarkers of inflammation.	Midpoint Chemotherapy, up to 4 months	No
Secondary	Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy	Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-ß, IL-6, TNF-a, CRP. These are the biomarkers of inflammation.	Midpoint Chemotherapy, up to 4 months	No
Secondary	Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy	Measured using Hospital Anxiety and Depression Scale (HADS) a fourteen item scale, 7 relate to anxiety and 7 to depression; each item is scored from 0-3, this means 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 of pain 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. it has 9 questions with 0 (does not interfere) to 10 (completely interferes); 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 scoring system.	Midpoint Chemotherapy, up to 4 months	No
Secondary	Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy	Simple correlations will be computed at Midpoint Chemotherapy for symptoms.	Midpoint Chemotherapy, up to 4 months	No
Secondary	Relationships Among Quality of Life Scores - Means at Midpoint Chemotherapy	Measured using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). A 44-item self-report instrument designed to measure multidimensional quality of life in patient with breast cancer. 0=not at all to 4=very much. Utilized standard questionnaire scoring system. The items are summed to produce a total score 0=not at all to 176=very much. The FACT-B BCA has 10 questions that range from 0 (not at all) to 4 (very much); thus the FACT-B BCA ranges from 0 to 40. Both the FACT-B and FACT-BCA are scored so that high scores indicate higher levels of quality of life.	Midpoint Chemotherapy, up to 4 months	No
Secondary	Relationships Among Quality of Life Scores - Correlations at Midpoint Chemotherapy	Simple correlations will be computed at Midpoint Chemotherapy for quality of life scores.	Midpoint Chemotherapy, up to 4 months	No
Secondary	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).	Simple correlations will be computed after completion of study treatment for the log transformed biomarker values; IL1-ß, IL-6, TNF-a, CRP. These are the biomarkers of inflammation.	Up to 2 weeks after completion of study treatment, for up to 8 months	No
Secondary	Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment	Simple correlations will be computed at Chemotherapy End of Treatment for the log transformed biomarker values; IL1-ß, IL-6, TNF-a, CRP. These are the biomarkers of inflammation.	Up to 2 weeks afer completion of study treatment, for up to 8 months	No
Secondary	Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy	Measured using Hospital Anxiety and Depression Scale (HADS) a fourteen item scale, 7 relate to anxiety and 7 to depression; each item is scored from 0-3, this means 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 of pain 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. it has 9 questions with 0 (does not interfere) to 10 (completely interferes); 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 scoring system.	Up to 2 weeks afer completion of study treatment, for up to 8 months	No
Secondary	Relationships Among Symptom Scores - Correlations at End of Chemotherapy	Simple correlations will be computed at end of Chemotherapy for symptoms.	Up to 2 weeks afer completion of study treatment, for up to 8 months	No
Secondary	Effects of Treatment on Quality of Life - Means at End of Treatment	Measured using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). A 44-item self-report instrument designed to measure multidimensional quality of life in patient with breast cancer. 0=not at all to 4=very much. Utilized standard questionnaire scoring system. The items are summed to produce a total score 0=not al all to 176=very much. The FACT-B BCA has 10 questions that range from 0 (not at all) to 4 (very much); thus the FACT-B BCA ranges from 0 to 40. Both the FACT-B and FACT-BCA are scored so that high scores indicate higher levels of quality of life.	up to 2 weeks after completion of study treatment, for up to 8 months	No
Secondary	Relationships Among Quality of Life Scores - Correlations at End of Chemotherapy	Simple correlations will be computed at End of Chemotherapy for quality of life scores.	Up to 2 weeks afer completion of study treatment, for up to 8 months	No