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Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer

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ClinicalTrials.gov Identifier: NCT00902330
Recruitment Status : Completed
First Posted : May 15, 2009
Results First Posted : April 2, 2015
Last Update Posted : November 23, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Anxiety Disorder
Breast Cancer
Depression
Fatigue
Pain
Sleep Disorders
Interventions Procedure: energy-based therapy
Procedure: sham intervention
Enrollment 161
Recruitment Details Women with stage I to IIIA breast cancer scheduled to receive chemotherapy with a performance score <2 recruited from five Cancer Centers across Virginia. Previous chemotherapy, dementia or active psychosis, seizure disorder, implanted electrical device, or taking medication psychiatric condition with 30 days prior to enrollment were excluded.
Pre-assignment Details Following completion of informed consent study participants were stratified by initial chemotherapy regimen (dose dense versus non-dose dense) and then randomly assigned to one of two groups: actual or sham CES.
Arm/Group Title Arm I (Cranial Microcurrent Electrical Stimulation [CES]) Arm II (Sham CES)
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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.

energy-based therapy: Given once a day for 18 weeks

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.

sham intervention: Given once a day for 18 weeks

Period Title: Overall Study
Started 81 80
Completed 77 75
Not Completed 4 5
Reason Not Completed
Too overwhelmed by treatment             2             5
Adverse Event             1             0
No post baseline data             1             0
Arm/Group Title Arm I (Cranial Microcurrent Electrical Stimulation [CES]) Arm II (Sham CES) Total
Hide Arm/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.

energy-based therapy: Given once a day for 18 weeks

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.

sham intervention: Given once a day for 18 weeks

Total of all reporting groups
Overall Number of Baseline Participants 77 75 152
Hide Baseline Analysis Population Description
Patients who completed trial
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 77 participants 75 participants 152 participants
51.03  (11.06) 51.41  (8.55) 51.22  (9.805)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 75 participants 152 participants
Female
77
 100.0%
75
 100.0%
152
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 75 participants 152 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
28
  36.4%
22
  29.3%
50
  32.9%
White
46
  59.7%
49
  65.3%
95
  62.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   3.9%
4
   5.3%
7
   4.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 77 participants 75 participants 152 participants
77 75 152
Stage of Disease   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 77 participants 75 participants 152 participants
Phase I 16 18 34
Phase II 51 43 94
Phase III 10 14 24
[1]
Measure Description: Staged with TNM classifications. The TNM system is based on the size and/or extent (reach) of the primary tumor (T), the amount of spread to nearby lymph nodes (N), and the presence of metastasis (M) or secondary tumors formed by the spread of cancer cells to other parts of the body.
1.Primary Outcome
Title 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
Hide Description 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
Time Frame Up to 2 weeks afer completion of study treatment, for up to 8 months
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[Not Specified]
Arm/Group Title Arm I (Cranial Microcurrent Electrical Stimulation [CES]) Arm II (Sham CES)
Hide Arm/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.

energy-based therapy: Given once a day for 18 weeks

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.

sham intervention: Given once a day for 18 weeks

Overall Number of Participants Analyzed 77 75
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
Anxiety 4.040  (0.419) 4.529  (0.431)
Depression 4.520  (0.398) 4.565  (0.407)
Fatigue 3.349  (0.294) 3.191  (0.301)
Pain 1.174  (0.197) 1.272  (0.202)
Sleep 38.235  (2.376) 40.474  (2.443)
2.Secondary Outcome
Title To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Hide Description 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.
Time Frame up to 2 weeks after completion of study treatment, for up to 8 months
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[Not Specified]
Arm/Group Title All Patients Analyzed
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All patients
Overall Number of Participants Analyzed 152
Measure Type: Number
Unit of Measure: Rotated factor loading multiplied by 100
Anxiety Factor 1 Loading-Baseline 20
Anxeity Factor 2 Loading-Baseline 85
Anxiety Factor 1 Loading-Midpoint Chemotherapy 89
Anxiety Factor 2 Loading-Midpoint Chemotherapy 9
Anxiety Factor 1 Loading-Post Chemotherapy 88
Anxiety Factor 2 Loading-Post Chemotherapy 22
Depression Factor 1 Loading-Baseline 16
Depression Factor 2 Loading-Baseline 87
Depression Factor 1 Loading-Midpoint Chemotherapy 76
Depression Factor 2 Loading-Midpoint Chemotherapy 43
Depression Factor 1 Loading-Post Chemotherapy 86
Depression Factor 2 Loading-Post Chemotherapy 31
Fatigue Factor 1 Loading-Baseline 85
Fatigue Factor 2 Loading-Baseline 16
Fatigue Factor 1 Loading-Midpoint Chemotherapy 63
Fatigue Factor 2 Loading-Midpoint Chemotherapy 59
Fatigue Factor 1 Loading-Post Chemotherapy 44
Fatigue Factor 2 Loading-Post Chemotherapy 73
Pain Factor 1 Loading-Baseline 83
Pain Factor 2 Loading-Baseline 12
Pain Factor 1 Loading-Midpoint Chemotherapy 18
Pain Factor 2 Loading-Midpoint Chemotherapy 94
Pain Factor 1 Loading-Post Chemotherapy 13
Pain Factor 2 Loading-Post Chemotherapy 89
Sleep Factor 1 Loading-Baseline 67
Sleep Factor 2 Loading-Baseline 48
Sleep Factor 1 Loading-Midpoint Chemotherapy 79
Sleep Factor 2 Loading-Midpoint Chemotherapy 31
Sleep Factor 1 Loading-Post Chemotherapy 52
Sleep Factor 2 Loading-Post Chemotherapy 67
3.Secondary Outcome
Title 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).
Hide Description Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.
Time Frame Baseline
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Per protocol, for all subjects with available data. No imputation was utilized.
Arm/Group Title Arm I Arm II
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Cranial Microcurrent Electrical Stimulation (CES)
Sham CES
Overall Number of Participants Analyzed 77 75
Mean (Standard Deviation)
Unit of Measure: Log(pg/ml)
Log(CRP pg/ml) 28.64  (1.67) 28.92  (1.32)
Log(IL-1b pg/ml) 9.88  (69.85) 32.60  (259.03)
Log(IL-6 pg/ml) 0.33  (2.65) 0.09  (3.21)
Log(TNF-a pg/ml) -0.63  (3.49) -0.19  (3.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I, Arm II
Comments Spearman correlation coefficients were computed for the biomarkers. P-Values shown are not adjusted for multiple comparisons. The a priori threshold for statistical significance was P less than 0.05. This information applies to all rows listed in the table.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).
Hide Description Simple correlations will be computed at Baseline for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients Analyzed
Hide Arm/Group Description:
All patients
Overall Number of Participants Analyzed 152
Measure Type: Number
Unit of Measure: correlation coefficient
Correlation between Log (CRP)-Log (IL-1B) 0.031
Correlation between Log (CRP)-Log IL6) 0.243
Correlation between Log (CRP)-Log (TNF-a) 0.002
Correlation between Log (IL-1B)-Log (IL6) 0.453
Correlation between Log (IL-1B)-Log (TNF-a) 0.570
Correlation between Log (IL6)-Log (TNF-a) 0.320
5.Secondary Outcome
Title Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline
Hide Description 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.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II
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Cranial Microcurrent Electrical Stimulation (CES)
Sham CES
Overall Number of Participants Analyzed 77 75
Mean (Standard Deviation)
Unit of Measure: units on a scale
Anxiety 7.09  (4.09) 7.59  (4.13)
Depression 3.03  (2.48) 3.06  (2.78)
Fatigue 1.95  (2.71) 2.63  (2.89)
Pain 1.24  (2.05) 1.45  (1.98)
Sleep 40.70  (24.83) 40.30  (23.87)
6.Secondary Outcome
Title Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy
Hide Description Simple correlations will be computed at Baseline Chemotherapy for symptoms.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients Analyzed
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All patients
Overall Number of Participants Analyzed 152
Measure Type: Number
Unit of Measure: correlation coefficient
Correlation between Anxiety-Depression 0.610
Correlation between Anxiety-Fatigue 0.303
Correlation between Anxiety-Pain 0.298
Correlation between Anxiety-Sleep 0.474
Correlation between Depression-Fatigue 0.343
Correlation between Depression-Pain 0.315
Correlation between Depression-Sleep 0.488
Correlation between Fatigue-Pain 0.482
Correlation between Fatigue-Sleep 0.492
Correlation between Pain-Sleep 0.388
7.Secondary Outcome
Title Relationships Among Quality of Life Scores - Means at Baseline
Hide Description 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.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II
Hide Arm/Group Description:
Cranial Microcurrent Electrical Stimulation (CES)
Sham CES
Overall Number of Participants Analyzed 77 75
Mean (Standard Deviation)
Unit of Measure: units on a scale
FACT-B Total 113.44  (17.65) 111.83  (17.91)
FACT-B BCA Specific 27.42  (5.05) 26.05  (6.04)
8.Secondary Outcome
Title Relationships Among Quality of Life Scores - Correlations at Baseline
Hide Description Simple correlations will be computed at Baseline for quality of life scores.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients Analyzed
Hide Arm/Group Description:
All patients
Overall Number of Participants Analyzed 152
Measure Type: Number
Unit of Measure: correlation coefficient
0.744
9.Secondary Outcome
Title 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).
Hide Description Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.
Time Frame Midpoint Chemotherapy, up to 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II
Hide Arm/Group Description:
Cranial Microcurrent Electrical Stimulation (CES)
Sham CES
Overall Number of Participants Analyzed 77 75
Mean (Standard Deviation)
Unit of Measure: Log (pg/ml)
Log (CRP) 28.62  (1.69) 29.09  (1.18)
Log (IL-1B) 6.52  (52.59) 24.68  (171.81)
Log (IL6) -0.22  (2.91) 0.55  (2.80)
Log (TNF-a) -0.89  (3.52) -0.15  (3.68)
10.Secondary Outcome
Title Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy
Hide Description Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.
Time Frame Midpoint Chemotherapy, up to 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients Analyzed
Hide Arm/Group Description:
All patients
Overall Number of Participants Analyzed 152
Measure Type: Number
Unit of Measure: correlation coefficient
Correlation between Log (CRP)-Log (IL-1B) 0.060
Correlation between Log (CRP)-Log IL6) 0.337
Correlation between Log (CRP)-Log (TNF-a) 0.102
Correlation between Log (IL-1B)-Log (IL6) 0.390
Correlation between Log (IL-1B)-Log (TNF-a) 0.593
Correlation between Log (IL6)-Log (TNF-a) 0.298
11.Secondary Outcome
Title Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy
Hide Description 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.
Time Frame Midpoint Chemotherapy, up to 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II
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Cranial Microcurrent Electrical Stimulation (CES)
Sham CES
Overall Number of Participants Analyzed 77 75
Mean (Standard Deviation)
Unit of Measure: units on a scale
Anxiety 4.40  (3.19) 4.98  (3.72)
Depression 4.24  (3.22) 4.02  (3.14)
Fatigue 3.15  (2.21) 3.14  (2.39)
Pain 1.25  (1.44) 1.09  (1.56)
Sleep 38.70  (18.28) 42.44  (21.73)
12.Secondary Outcome
Title Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy
Hide Description Simple correlations will be computed at Midpoint Chemotherapy for symptoms.
Time Frame Midpoint Chemotherapy, up to 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients Analyzed
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All patients
Overall Number of Participants Analyzed 152
Measure Type: Number
Unit of Measure: correlation coefficient
Correlation between Anxiety-Depression 0.723
Correlation between Anxiety-Fatigue 0.512
Correlation between Anxiety-Pain 0.305
Correlation between Anxiety-Sleep 0.604
Correlation between Depression-Fatigue 0.632
Correlation between Depression-Pain 0.412
Correlation between Depression-Sleep 0.624
Correlation between Fatigue-Pain 0.507
Correlation between Fatigue-Sleep 0.719
Correlation between Pain-Sleep 0.429
13.Secondary Outcome
Title Relationships Among Quality of Life Scores - Means at Midpoint Chemotherapy
Hide Description 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.
Time Frame Midpoint Chemotherapy, up to 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II
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Cranial Microcurrent Electrical Stimulation (CES)
Sham CES
Overall Number of Participants Analyzed 77 75
Mean (Standard Deviation)
Unit of Measure: units on a scale
FACT-B Total 111.57  (18.35) 108.45  (22.46)
FACT-B BCA Specific 26.96  (5.47) 25.96  (5.39)
14.Secondary Outcome
Title Relationships Among Quality of Life Scores - Correlations at Midpoint Chemotherapy
Hide Description Simple correlations will be computed at Midpoint Chemotherapy for quality of life scores.
Time Frame Midpoint Chemotherapy, up to 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients Analyzed
Hide Arm/Group Description:
All patients
Overall Number of Participants Analyzed 152
Measure Type: Number
Unit of Measure: correlation coefficient
0.743
15.Secondary Outcome
Title 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).
Hide Description Simple correlations will be computed after completion of study treatment for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.
Time Frame Up to 2 weeks after completion of study treatment, for up to 8 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II
Hide Arm/Group Description:
Cranial Microcurrent Electrical Stimulation (CES)
Sham CES
Overall Number of Participants Analyzed 77 75
Mean (Standard Deviation)
Unit of Measure: Log (pg/ml)
Log (CRP) 28.64  (1.26) 29.00  (1.32)
Log (IL-1B) 10.50  (83.81) 1.35  (5.65)
Log (IL6) 0.68  (2.29) 0.73  (2.26)
Log (TNF-a) -1.34  (3.64) -0.33  (3.22)
16.Secondary Outcome
Title Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment
Hide Description Simple correlations will be computed at Chemotherapy End of Treatment for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.
Time Frame Up to 2 weeks afer completion of study treatment, for up to 8 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients Analyzed
Hide Arm/Group Description:
All patients
Overall Number of Participants Analyzed 152
Measure Type: Number
Unit of Measure: correlation coefficient
Correlation between Log (CRP)-Log (IL-1B) 0.057
Correlation between Log (CRP)-Log IL6) 0.343
Correlation between Log (CRP)-Log (TNF-a) 0.135
Correlation between Log (IL-1B)-Log (IL6) 0.383
Correlation between Log (IL-1B)-Log (TNF-a) 0.464
Correlation between Log (IL6)-Log (TNF-a) 0.134
17.Secondary Outcome
Title Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy
Hide Description 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.
Time Frame Up to 2 weeks afer completion of study treatment, for up to 8 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I Arm II
Hide Arm/Group Description:
Cranial Microcurrent Electrical Stimulation (CES)
Sham CES
Overall Number of Participants Analyzed 77 75
Mean (Standard Deviation)
Unit of Measure: units on a scale
Anxiety 4.07  (3.51) 4.51  (4.04)
Depression 4.47  (3.36) 4.63  (3.67)
Fatigue 3.34  (2.47) 3.32  (2.55)
Pain 1.14  (1.65) 1.32  (1.80)
Sleep 38.50  (20.19) 40.91  (21.21)
18.Secondary Outcome
Title Relationships Among Symptom Scores - Correlations at End of Chemotherapy
Hide Description Simple correlations will be computed at end of Chemotherapy for symptoms.
Time Frame Up to 2 weeks afer completion of study treatment, for up to 8 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients Analyzed
Hide Arm/Group Description:
All patients
Overall Number of Participants Analyzed 152
Measure Type: Number
Unit of Measure: correlation coefficient
Correlation between Anxiety-Depression 0.678
Correlation between Anxiety-Fatigue 0.467
Correlation between Anxiety-Pain 0.409
Correlation between Anxiety-Sleep 0.515
Correlation between Depression-Fatigue 0.564
Correlation between Depression-Pain 0.368
Correlation between Depression-Sleep 0.637
Correlation between Fatigue-Pain 0.488
Correlation between Fatigue-Sleep 0.643
Correlation between Pain-Sleep 0.484
19.Secondary Outcome
Title Effects of Treatment on Quality of Life - Means at End of Treatment
Hide Description 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.
Time Frame up to 2 weeks after completion of study treatment, for up to 8 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Cranial Microcurrent Electrical Stimulation [CES]) Arm II (Sham CES)
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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.

energy-based therapy: Given once a day for 18 weeks

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.

sham intervention: Given once a day for 18 weeks

Overall Number of Participants Analyzed 77 75
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Total Score 108.11  (2.52) 105.96  (2.59)
Breast Cancer Specific 25.51  (0.75) 24.66  (0.77)
20.Secondary Outcome
Title Relationships Among Quality of Life Scores - Correlations at End of Chemotherapy
Hide Description Simple correlations will be computed at End of Chemotherapy for quality of life scores.
Time Frame Up to 2 weeks afer completion of study treatment, for up to 8 months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients Analyzed
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All patients
Overall Number of Participants Analyzed 152
Measure Type: Number
Unit of Measure: correlation coefficient
0.772
Time Frame Up to 20 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Cranial Microcurrent Electrical Stimulation [CES]) Arm II (Sham CES)
Hide Arm/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.

energy-based therapy: Given once a day for 18 weeks

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.

sham intervention: Given once a day for 18 weeks

All-Cause Mortality
Arm I (Cranial Microcurrent Electrical Stimulation [CES]) Arm II (Sham CES)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Cranial Microcurrent Electrical Stimulation [CES]) Arm II (Sham CES)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/77 (1.30%)      0/75 (0.00%)    
Nervous system disorders     
Seizure * 1 [1]  1/77 (1.30%)  1 0/75 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, NCI CTCAE v3.0
[1]
nonstudy related
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (Cranial Microcurrent Electrical Stimulation [CES]) Arm II (Sham CES)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/77 (0.00%)      0/75 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Debra Lyon, RN, PhD, FNP
Organization: Virginia Commonwealth University
Phone: 804-828-7743
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00902330     History of Changes
Other Study ID Numbers: MCC-11995
HM11995 ( Other Identifier: VCU IRB )
CDR0000641994 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2011-00234 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
First Submitted: May 14, 2009
First Posted: May 15, 2009
Results First Submitted: May 15, 2014
Results First Posted: April 2, 2015
Last Update Posted: November 23, 2015