Trial Outcomes & Findings for Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer (NCT NCT00902330)
NCT ID: NCT00902330
Last Updated: 2015-11-23
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
161 participants
Primary outcome timeframe
Up to 2 weeks afer completion of study treatment, for up to 8 months
Results posted on
2015-11-23
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
energy-based therapy: 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.
sham intervention: Given once a day for 18 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
80
|
|
Overall Study
COMPLETED
|
77
|
75
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
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.
energy-based therapy: 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.
sham intervention: Given once a day for 18 weeks
|
|---|---|---|
|
Overall Study
Too overwhelmed by treatment
|
2
|
5
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
No post baseline data
|
1
|
0
|
Baseline Characteristics
Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Cranial Microcurrent Electrical Stimulation [CES])
n=77 Participants
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
|
Arm II (Sham CES)
n=75 Participants
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
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.03 years
STANDARD_DEVIATION 11.06 • n=5 Participants
|
51.41 years
STANDARD_DEVIATION 8.55 • n=7 Participants
|
51.22 years
STANDARD_DEVIATION 9.805 • n=5 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
77 participants
n=5 Participants
|
75 participants
n=7 Participants
|
152 participants
n=5 Participants
|
|
Stage of Disease
Phase I
|
16 participants
n=5 Participants
|
18 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Stage of Disease
Phase II
|
51 participants
n=5 Participants
|
43 participants
n=7 Participants
|
94 participants
n=5 Participants
|
|
Stage of Disease
Phase III
|
10 participants
n=5 Participants
|
14 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 weeks afer completion of study treatment, for up to 8 monthsUsing 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
Outcome measures
| Measure |
Arm I (Cranial Microcurrent Electrical Stimulation [CES])
n=77 Participants
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
|
Arm II (Sham CES)
n=75 Participants
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
|
|---|---|---|
|
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
Anxiety
|
4.040 units on a scale
Standard Deviation 0.419
|
4.529 units on a scale
Standard Deviation 0.431
|
|
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
Depression
|
4.520 units on a scale
Standard Deviation 0.398
|
4.565 units on a scale
Standard Deviation 0.407
|
|
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
Fatigue
|
3.349 units on a scale
Standard Deviation 0.294
|
3.191 units on a scale
Standard Deviation 0.301
|
|
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
Pain
|
1.174 units on a scale
Standard Deviation 0.197
|
1.272 units on a scale
Standard Deviation 0.202
|
|
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
Sleep
|
38.235 units on a scale
Standard Deviation 2.376
|
40.474 units on a scale
Standard Deviation 2.443
|
SECONDARY outcome
Timeframe: up to 2 weeks after completion of study treatment, for up to 8 monthsExamine 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.
Outcome measures
| Measure |
Arm I (Cranial Microcurrent Electrical Stimulation [CES])
n=152 Participants
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
|
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.
sham intervention: Given once a day for 18 weeks
|
|---|---|---|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Anxiety Factor 1 Loading-Baseline
|
20 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Anxeity Factor 2 Loading-Baseline
|
85 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Anxiety Factor 1 Loading-Midpoint Chemotherapy
|
89 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Anxiety Factor 2 Loading-Midpoint Chemotherapy
|
9 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Anxiety Factor 1 Loading-Post Chemotherapy
|
88 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Anxiety Factor 2 Loading-Post Chemotherapy
|
22 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Depression Factor 1 Loading-Baseline
|
16 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Depression Factor 2 Loading-Baseline
|
87 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Depression Factor 1 Loading-Midpoint Chemotherapy
|
76 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Depression Factor 2 Loading-Midpoint Chemotherapy
|
43 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Depression Factor 1 Loading-Post Chemotherapy
|
86 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Depression Factor 2 Loading-Post Chemotherapy
|
31 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Fatigue Factor 1 Loading-Baseline
|
85 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Fatigue Factor 2 Loading-Baseline
|
16 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Fatigue Factor 1 Loading-Midpoint Chemotherapy
|
63 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Fatigue Factor 2 Loading-Midpoint Chemotherapy
|
59 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Fatigue Factor 1 Loading-Post Chemotherapy
|
44 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Fatigue Factor 2 Loading-Post Chemotherapy
|
73 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Pain Factor 1 Loading-Baseline
|
83 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Pain Factor 2 Loading-Baseline
|
12 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Pain Factor 1 Loading-Midpoint Chemotherapy
|
18 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Pain Factor 2 Loading-Midpoint Chemotherapy
|
94 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Pain Factor 1 Loading-Post Chemotherapy
|
13 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Pain Factor 2 Loading-Post Chemotherapy
|
89 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Sleep Factor 1 Loading-Baseline
|
67 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Sleep Factor 2 Loading-Baseline
|
48 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Sleep Factor 1 Loading-Midpoint Chemotherapy
|
79 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Sleep Factor 2 Loading-Midpoint Chemotherapy
|
31 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Sleep Factor 1 Loading-Post Chemotherapy
|
52 Rotated factor loading multiplied by 100
|
—
|
|
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Sleep Factor 2 Loading-Post Chemotherapy
|
67 Rotated factor loading multiplied by 100
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Per protocol, for all subjects with available data. No imputation was utilized.
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.
Outcome measures
| Measure |
Arm I (Cranial Microcurrent Electrical Stimulation [CES])
n=77 Participants
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
|
Arm II (Sham CES)
n=75 Participants
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
|
|---|---|---|
|
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).
Log(CRP pg/ml)
|
28.64 Log(pg/ml)
Standard Deviation 1.67
|
28.92 Log(pg/ml)
Standard Deviation 1.32
|
|
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).
Log(IL-1b pg/ml)
|
9.88 Log(pg/ml)
Standard Deviation 69.85
|
32.60 Log(pg/ml)
Standard Deviation 259.03
|
|
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).
Log(IL-6 pg/ml)
|
0.33 Log(pg/ml)
Standard Deviation 2.65
|
0.09 Log(pg/ml)
Standard Deviation 3.21
|
|
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).
Log(TNF-a pg/ml)
|
-0.63 Log(pg/ml)
Standard Deviation 3.49
|
-0.19 Log(pg/ml)
Standard Deviation 3.49
|
SECONDARY outcome
Timeframe: BaselineSimple 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.
Outcome measures
| Measure |
Arm I (Cranial Microcurrent Electrical Stimulation [CES])
n=152 Participants
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
|
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.
sham intervention: Given once a day for 18 weeks
|
|---|---|---|
|
Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).
Correlation between Log (IL-1B)-Log (IL6)
|
0.453 correlation coefficient
|
—
|
|
Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).
Correlation between Log (CRP)-Log (IL-1B)
|
0.031 correlation coefficient
|
—
|
|
Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).
Correlation between Log (CRP)-Log IL6)
|
0.243 correlation coefficient
|
—
|
|
Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).
Correlation between Log (CRP)-Log (TNF-a)
|
0.002 correlation coefficient
|
—
|
|
Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).
Correlation between Log (IL-1B)-Log (TNF-a)
|
0.570 correlation coefficient
|
—
|
|
Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).
Correlation between Log (IL6)-Log (TNF-a)
|
0.320 correlation coefficient
|
—
|
SECONDARY outcome
Timeframe: BaselineMeasured 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.
Outcome measures
| Measure |
Arm I (Cranial Microcurrent Electrical Stimulation [CES])
n=77 Participants
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
|
Arm II (Sham CES)
n=75 Participants
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
|
|---|---|---|
|
Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline
Anxiety
|
7.09 units on a scale
Standard Deviation 4.09
|
7.59 units on a scale
Standard Deviation 4.13
|
|
Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline
Depression
|
3.03 units on a scale
Standard Deviation 2.48
|
3.06 units on a scale
Standard Deviation 2.78
|
|
Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline
Fatigue
|
1.95 units on a scale
Standard Deviation 2.71
|
2.63 units on a scale
Standard Deviation 2.89
|
|
Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline
Pain
|
1.24 units on a scale
Standard Deviation 2.05
|
1.45 units on a scale
Standard Deviation 1.98
|
|
Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline
Sleep
|
40.70 units on a scale
Standard Deviation 24.83
|
40.30 units on a scale
Standard Deviation 23.87
|
SECONDARY outcome
Timeframe: BaselineSimple correlations will be computed at Baseline Chemotherapy for symptoms.
Outcome measures
| Measure |
Arm I (Cranial Microcurrent Electrical Stimulation [CES])
n=152 Participants
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
|
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.
sham intervention: Given once a day for 18 weeks
|
|---|---|---|
|
Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy
Correlation between Anxiety-Depression
|
0.610 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy
Correlation between Anxiety-Fatigue
|
0.303 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy
Correlation between Anxiety-Pain
|
0.298 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy
Correlation between Anxiety-Sleep
|
0.474 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy
Correlation between Depression-Fatigue
|
0.343 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy
Correlation between Depression-Pain
|
0.315 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy
Correlation between Depression-Sleep
|
0.488 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy
Correlation between Fatigue-Pain
|
0.482 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy
Correlation between Fatigue-Sleep
|
0.492 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy
Correlation between Pain-Sleep
|
0.388 correlation coefficient
|
—
|
SECONDARY outcome
Timeframe: BaselineMeasured 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.
Outcome measures
| Measure |
Arm I (Cranial Microcurrent Electrical Stimulation [CES])
n=77 Participants
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
|
Arm II (Sham CES)
n=75 Participants
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
|
|---|---|---|
|
Relationships Among Quality of Life Scores - Means at Baseline
FACT-B Total
|
113.44 units on a scale
Standard Deviation 17.65
|
111.83 units on a scale
Standard Deviation 17.91
|
|
Relationships Among Quality of Life Scores - Means at Baseline
FACT-B BCA Specific
|
27.42 units on a scale
Standard Deviation 5.05
|
26.05 units on a scale
Standard Deviation 6.04
|
SECONDARY outcome
Timeframe: BaselineSimple correlations will be computed at Baseline for quality of life scores.
Outcome measures
| Measure |
Arm I (Cranial Microcurrent Electrical Stimulation [CES])
n=152 Participants
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
|
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.
sham intervention: Given once a day for 18 weeks
|
|---|---|---|
|
Relationships Among Quality of Life Scores - Correlations at Baseline
|
0.744 correlation coefficient
|
—
|
SECONDARY outcome
Timeframe: Midpoint Chemotherapy, up to 4 monthsSimple 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.
Outcome measures
| Measure |
Arm I (Cranial Microcurrent Electrical Stimulation [CES])
n=77 Participants
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
|
Arm II (Sham CES)
n=75 Participants
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
|
|---|---|---|
|
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).
Log (CRP)
|
28.62 Log (pg/ml)
Standard Deviation 1.69
|
29.09 Log (pg/ml)
Standard Deviation 1.18
|
|
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).
Log (IL-1B)
|
6.52 Log (pg/ml)
Standard Deviation 52.59
|
24.68 Log (pg/ml)
Standard Deviation 171.81
|
|
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).
Log (IL6)
|
-0.22 Log (pg/ml)
Standard Deviation 2.91
|
0.55 Log (pg/ml)
Standard Deviation 2.80
|
|
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).
Log (TNF-a)
|
-0.89 Log (pg/ml)
Standard Deviation 3.52
|
-0.15 Log (pg/ml)
Standard Deviation 3.68
|
SECONDARY outcome
Timeframe: Midpoint Chemotherapy, up to 4 monthsSimple 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.
Outcome measures
| Measure |
Arm I (Cranial Microcurrent Electrical Stimulation [CES])
n=152 Participants
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
|
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.
sham intervention: Given once a day for 18 weeks
|
|---|---|---|
|
Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy
Correlation between Log (CRP)-Log (IL-1B)
|
0.060 correlation coefficient
|
—
|
|
Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy
Correlation between Log (CRP)-Log IL6)
|
0.337 correlation coefficient
|
—
|
|
Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy
Correlation between Log (CRP)-Log (TNF-a)
|
0.102 correlation coefficient
|
—
|
|
Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy
Correlation between Log (IL-1B)-Log (IL6)
|
0.390 correlation coefficient
|
—
|
|
Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy
Correlation between Log (IL-1B)-Log (TNF-a)
|
0.593 correlation coefficient
|
—
|
|
Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy
Correlation between Log (IL6)-Log (TNF-a)
|
0.298 correlation coefficient
|
—
|
SECONDARY outcome
Timeframe: Midpoint Chemotherapy, up to 4 monthsMeasured 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.
Outcome measures
| Measure |
Arm I (Cranial Microcurrent Electrical Stimulation [CES])
n=77 Participants
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
|
Arm II (Sham CES)
n=75 Participants
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
|
|---|---|---|
|
Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy
Anxiety
|
4.40 units on a scale
Standard Deviation 3.19
|
4.98 units on a scale
Standard Deviation 3.72
|
|
Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy
Depression
|
4.24 units on a scale
Standard Deviation 3.22
|
4.02 units on a scale
Standard Deviation 3.14
|
|
Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy
Fatigue
|
3.15 units on a scale
Standard Deviation 2.21
|
3.14 units on a scale
Standard Deviation 2.39
|
|
Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy
Pain
|
1.25 units on a scale
Standard Deviation 1.44
|
1.09 units on a scale
Standard Deviation 1.56
|
|
Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy
Sleep
|
38.70 units on a scale
Standard Deviation 18.28
|
42.44 units on a scale
Standard Deviation 21.73
|
SECONDARY outcome
Timeframe: Midpoint Chemotherapy, up to 4 monthsSimple correlations will be computed at Midpoint Chemotherapy for symptoms.
Outcome measures
| Measure |
Arm I (Cranial Microcurrent Electrical Stimulation [CES])
n=152 Participants
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
|
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.
sham intervention: Given once a day for 18 weeks
|
|---|---|---|
|
Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy
Correlation between Depression-Sleep
|
0.624 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy
Correlation between Fatigue-Pain
|
0.507 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy
Correlation between Anxiety-Depression
|
0.723 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy
Correlation between Anxiety-Fatigue
|
0.512 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy
Correlation between Anxiety-Pain
|
0.305 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy
Correlation between Anxiety-Sleep
|
0.604 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy
Correlation between Depression-Fatigue
|
0.632 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy
Correlation between Depression-Pain
|
0.412 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy
Correlation between Fatigue-Sleep
|
0.719 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy
Correlation between Pain-Sleep
|
0.429 correlation coefficient
|
—
|
SECONDARY outcome
Timeframe: Midpoint Chemotherapy, up to 4 monthsMeasured 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.
Outcome measures
| Measure |
Arm I (Cranial Microcurrent Electrical Stimulation [CES])
n=77 Participants
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
|
Arm II (Sham CES)
n=75 Participants
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
|
|---|---|---|
|
Relationships Among Quality of Life Scores - Means at Midpoint Chemotherapy
FACT-B Total
|
111.57 units on a scale
Standard Deviation 18.35
|
108.45 units on a scale
Standard Deviation 22.46
|
|
Relationships Among Quality of Life Scores - Means at Midpoint Chemotherapy
FACT-B BCA Specific
|
26.96 units on a scale
Standard Deviation 5.47
|
25.96 units on a scale
Standard Deviation 5.39
|
SECONDARY outcome
Timeframe: Midpoint Chemotherapy, up to 4 monthsSimple correlations will be computed at Midpoint Chemotherapy for quality of life scores.
Outcome measures
| Measure |
Arm I (Cranial Microcurrent Electrical Stimulation [CES])
n=152 Participants
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
|
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.
sham intervention: Given once a day for 18 weeks
|
|---|---|---|
|
Relationships Among Quality of Life Scores - Correlations at Midpoint Chemotherapy
|
0.743 correlation coefficient
|
—
|
SECONDARY outcome
Timeframe: Up to 2 weeks after completion of study treatment, for up to 8 monthsSimple 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.
Outcome measures
| Measure |
Arm I (Cranial Microcurrent Electrical Stimulation [CES])
n=77 Participants
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
|
Arm II (Sham CES)
n=75 Participants
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
|
|---|---|---|
|
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).
Log (CRP)
|
28.64 Log (pg/ml)
Standard Deviation 1.26
|
29.00 Log (pg/ml)
Standard Deviation 1.32
|
|
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).
Log (IL-1B)
|
10.50 Log (pg/ml)
Standard Deviation 83.81
|
1.35 Log (pg/ml)
Standard Deviation 5.65
|
|
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).
Log (IL6)
|
0.68 Log (pg/ml)
Standard Deviation 2.29
|
0.73 Log (pg/ml)
Standard Deviation 2.26
|
|
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).
Log (TNF-a)
|
-1.34 Log (pg/ml)
Standard Deviation 3.64
|
-0.33 Log (pg/ml)
Standard Deviation 3.22
|
SECONDARY outcome
Timeframe: Up to 2 weeks afer completion of study treatment, for up to 8 monthsSimple 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.
Outcome measures
| Measure |
Arm I (Cranial Microcurrent Electrical Stimulation [CES])
n=152 Participants
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
|
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.
sham intervention: Given once a day for 18 weeks
|
|---|---|---|
|
Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment
Correlation between Log (CRP)-Log (TNF-a)
|
0.135 correlation coefficient
|
—
|
|
Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment
Correlation between Log (IL-1B)-Log (IL6)
|
0.383 correlation coefficient
|
—
|
|
Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment
Correlation between Log (CRP)-Log (IL-1B)
|
0.057 correlation coefficient
|
—
|
|
Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment
Correlation between Log (CRP)-Log IL6)
|
0.343 correlation coefficient
|
—
|
|
Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment
Correlation between Log (IL-1B)-Log (TNF-a)
|
0.464 correlation coefficient
|
—
|
|
Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment
Correlation between Log (IL6)-Log (TNF-a)
|
0.134 correlation coefficient
|
—
|
SECONDARY outcome
Timeframe: Up to 2 weeks afer completion of study treatment, for up to 8 monthsMeasured 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.
Outcome measures
| Measure |
Arm I (Cranial Microcurrent Electrical Stimulation [CES])
n=77 Participants
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
|
Arm II (Sham CES)
n=75 Participants
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
|
|---|---|---|
|
Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy
Anxiety
|
4.07 units on a scale
Standard Deviation 3.51
|
4.51 units on a scale
Standard Deviation 4.04
|
|
Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy
Depression
|
4.47 units on a scale
Standard Deviation 3.36
|
4.63 units on a scale
Standard Deviation 3.67
|
|
Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy
Fatigue
|
3.34 units on a scale
Standard Deviation 2.47
|
3.32 units on a scale
Standard Deviation 2.55
|
|
Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy
Pain
|
1.14 units on a scale
Standard Deviation 1.65
|
1.32 units on a scale
Standard Deviation 1.80
|
|
Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy
Sleep
|
38.50 units on a scale
Standard Deviation 20.19
|
40.91 units on a scale
Standard Deviation 21.21
|
SECONDARY outcome
Timeframe: Up to 2 weeks afer completion of study treatment, for up to 8 monthsSimple correlations will be computed at end of Chemotherapy for symptoms.
Outcome measures
| Measure |
Arm I (Cranial Microcurrent Electrical Stimulation [CES])
n=152 Participants
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
|
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.
sham intervention: Given once a day for 18 weeks
|
|---|---|---|
|
Relationships Among Symptom Scores - Correlations at End of Chemotherapy
Correlation between Anxiety-Depression
|
0.678 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at End of Chemotherapy
Correlation between Anxiety-Fatigue
|
0.467 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at End of Chemotherapy
Correlation between Anxiety-Pain
|
0.409 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at End of Chemotherapy
Correlation between Anxiety-Sleep
|
0.515 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at End of Chemotherapy
Correlation between Depression-Fatigue
|
0.564 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at End of Chemotherapy
Correlation between Depression-Pain
|
0.368 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at End of Chemotherapy
Correlation between Depression-Sleep
|
0.637 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at End of Chemotherapy
Correlation between Fatigue-Pain
|
0.488 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at End of Chemotherapy
Correlation between Fatigue-Sleep
|
0.643 correlation coefficient
|
—
|
|
Relationships Among Symptom Scores - Correlations at End of Chemotherapy
Correlation between Pain-Sleep
|
0.484 correlation coefficient
|
—
|
SECONDARY outcome
Timeframe: up to 2 weeks after completion of study treatment, for up to 8 monthsMeasured 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.
Outcome measures
| Measure |
Arm I (Cranial Microcurrent Electrical Stimulation [CES])
n=77 Participants
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
|
Arm II (Sham CES)
n=75 Participants
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
|
|---|---|---|
|
Effects of Treatment on Quality of Life - Means at End of Treatment
Total Score
|
108.11 units on a scale
Standard Error 2.52
|
105.96 units on a scale
Standard Error 2.59
|
|
Effects of Treatment on Quality of Life - Means at End of Treatment
Breast Cancer Specific
|
25.51 units on a scale
Standard Error 0.75
|
24.66 units on a scale
Standard Error 0.77
|
SECONDARY outcome
Timeframe: Up to 2 weeks afer completion of study treatment, for up to 8 monthsSimple correlations will be computed at End of Chemotherapy for quality of life scores.
Outcome measures
| Measure |
Arm I (Cranial Microcurrent Electrical Stimulation [CES])
n=152 Participants
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
|
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.
sham intervention: Given once a day for 18 weeks
|
|---|---|---|
|
Relationships Among Quality of Life Scores - Correlations at End of Chemotherapy
|
0.772 correlation coefficient
|
—
|
Adverse Events
Arm I (Cranial Microcurrent Electrical Stimulation [CES])
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm II (Sham CES)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Cranial Microcurrent Electrical Stimulation [CES])
n=77 participants at risk
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
|
Arm II (Sham CES)
n=75 participants at risk
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
|
|---|---|---|
|
Nervous system disorders
Seizure
|
1.3%
1/77 • Number of events 1 • Up to 20 weeks
|
0.00%
0/75 • Up to 20 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Debra Lyon, RN, PhD, FNP
Virginia Commonwealth University
Phone: 804-828-7743
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place