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| ID | Type | Description | Link |
|---|---|---|---|
| HM11995 | Other Identifier | VCU IRB | |
| CDR0000641994 | Registry Identifier | PDQ (Physician Data Query) | |
| NCI-2011-00234 | Registry Identifier | CTRP (Clinical Trials Reporting System) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (cranial microcurrent electrical stimulation [CES]) | Experimental | Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18. |
|
| Arm II (sham CES) | Sham Comparator | Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| energy-based therapy | Procedure | Given once a day for 18 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah McGuire, PhD,RN,FAAN | Massey Cancer Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26435889 | Derived | Lyon D, Kelly D, Walter J, Bear H, Thacker L, Elswick RK. Randomized sham controlled trial of cranial microcurrent stimulation for symptoms of depression, anxiety, pain, fatigue and sleep disturbances in women receiving chemotherapy for early-stage breast cancer. Springerplus. 2015 Jul 23;4:369. doi: 10.1186/s40064-015-1151-z. eCollection 2015. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients who completed trial
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Least Squares Mean | Standard Deviation | units on a scale | Up to 2 weeks afer completion of study treatment, for up to 8 months |
Up to 20 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | NCI CTCAE v3.0 | Non-systematic Assessment | nonstudy related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Debra Lyon, RN, PhD, FNP | Virginia Commonwealth University | 804-828-7743 | delyon@vcu.edu |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001943 | Breast Neoplasms |
| D003863 | Depression |
| D005221 | Fatigue |
| D010146 | Pain |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| sham intervention | Procedure | Given once a day for 18 weeks |
|
| up to 2 weeks after completion of study treatment, for up to 8 months |
| Means and Standard Deviations of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | 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. | Baseline |
| 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-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation. | Baseline |
| 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 |
| Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy | Simple correlations will be computed at Baseline Chemotherapy for symptoms. | Baseline |
| 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 |
| Relationships Among Quality of Life Scores - Correlations at Baseline | Simple correlations will be computed at Baseline for quality of life scores. | Baseline |
| 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-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation. | Midpoint Chemotherapy, up to 4 months |
| 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-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation. | Midpoint Chemotherapy, up to 4 months |
| 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 |
| Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy | Simple correlations will be computed at Midpoint Chemotherapy for symptoms. | Midpoint Chemotherapy, up to 4 months |
| 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 |
| 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 |
| 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-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation. | Up to 2 weeks after completion of study treatment, for up to 8 months |
| 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-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation. | Up to 2 weeks afer completion of study treatment, for up to 8 months |
| 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 |
| 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 |
| 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 |
| 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 post baseline data |
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Stage of Disease | 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. | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | 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 |
| OG001 | 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 |
|
|
| 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. | Posted | Number | Rotated factor loading multiplied by 100 | up to 2 weeks after completion of study treatment, for up to 8 months |
|
|
|
| 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-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation. | Per protocol, for all subjects with available data. No imputation was utilized. | Posted | Mean | Standard Deviation | Log(pg/ml) | Baseline |
|
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|
|
| 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-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation. | Posted | Number | correlation coefficient | Baseline |
|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Secondary | Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy | Simple correlations will be computed at Baseline Chemotherapy for symptoms. | Posted | Number | correlation coefficient | Baseline |
|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
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| Secondary | Relationships Among Quality of Life Scores - Correlations at Baseline | Simple correlations will be computed at Baseline for quality of life scores. | Posted | Number | correlation coefficient | Baseline |
|
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| 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-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation. | Posted | Mean | Standard Deviation | Log (pg/ml) | Midpoint Chemotherapy, up to 4 months |
|
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| 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-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation. | Posted | Number | correlation coefficient | Midpoint Chemotherapy, up to 4 months |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Midpoint Chemotherapy, up to 4 months |
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| Secondary | Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy | Simple correlations will be computed at Midpoint Chemotherapy for symptoms. | Posted | Number | correlation coefficient | Midpoint Chemotherapy, up to 4 months |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Midpoint Chemotherapy, up to 4 months |
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| Secondary | Relationships Among Quality of Life Scores - Correlations at Midpoint Chemotherapy | Simple correlations will be computed at Midpoint Chemotherapy for quality of life scores. | Posted | Number | correlation coefficient | Midpoint Chemotherapy, up to 4 months |
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| 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-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation. | Posted | Mean | Standard Deviation | Log (pg/ml) | Up to 2 weeks after completion of study treatment, for up to 8 months |
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| 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-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation. | Posted | Number | correlation coefficient | Up to 2 weeks afer completion of study treatment, for up to 8 months |
|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Up to 2 weeks afer completion of study treatment, for up to 8 months |
|
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| Secondary | Relationships Among Symptom Scores - Correlations at End of Chemotherapy | Simple correlations will be computed at end of Chemotherapy for symptoms. | Posted | Number | correlation coefficient | Up to 2 weeks afer completion of study treatment, for up to 8 months |
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| 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. | Posted | Least Squares Mean | Standard Error | units on a scale | up to 2 weeks after completion of study treatment, for up to 8 months |
|
|
|
| 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. | Posted | Number | correlation coefficient | Up to 2 weeks afer completion of study treatment, for up to 8 months |
|
|
|
| 1 |
| 77 |
| 0 |
| 77 |
| EG001 | 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 | 0 | 75 | 0 | 75 |
|
Not provided
Not provided
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| Title | Measurements |
|---|---|
|
| Anxiety Factor 2 Loading-Midpoint Chemotherapy |
|
| Anxiety Factor 1 Loading-Post Chemotherapy |
|
| Anxiety Factor 2 Loading-Post Chemotherapy |
|
| Depression Factor 1 Loading-Baseline |
|
| Depression Factor 2 Loading-Baseline |
|
| Depression Factor 1 Loading-Midpoint Chemotherapy |
|
| Depression Factor 2 Loading-Midpoint Chemotherapy |
|
| Depression Factor 1 Loading-Post Chemotherapy |
|
| Depression Factor 2 Loading-Post Chemotherapy |
|
| Fatigue Factor 1 Loading-Baseline |
|
| Fatigue Factor 2 Loading-Baseline |
|
| Fatigue Factor 1 Loading-Midpoint Chemotherapy |
|
| Fatigue Factor 2 Loading-Midpoint Chemotherapy |
|
| Fatigue Factor 1 Loading-Post Chemotherapy |
|
| Fatigue Factor 2 Loading-Post Chemotherapy |
|
| Pain Factor 1 Loading-Baseline |
|
| Pain Factor 2 Loading-Baseline |
|
| Pain Factor 1 Loading-Midpoint Chemotherapy |
|
| Pain Factor 2 Loading-Midpoint Chemotherapy |
|
| Pain Factor 1 Loading-Post Chemotherapy |
|
| Pain Factor 2 Loading-Post Chemotherapy |
|
| Sleep Factor 1 Loading-Baseline |
|
| Sleep Factor 2 Loading-Baseline |
|
| Sleep Factor 1 Loading-Midpoint Chemotherapy |
|
| Sleep Factor 2 Loading-Midpoint Chemotherapy |
|
| Sleep Factor 1 Loading-Post Chemotherapy |
|
| Sleep Factor 2 Loading-Post Chemotherapy |
|
| Log(IL-6 pg/ml) |
|
| Log(TNF-a pg/ml) |
|
|
| Correlation between Log (IL-1B)-Log (IL6) |
|
| Correlation between Log (IL-1B)-Log (TNF-a) |
|
| Correlation between Log (IL6)-Log (TNF-a) |
|
| Fatigue |
|
| Pain |
|
| Sleep |
|
| Log (IL6) |
|
| Log (TNF-a) |
|
|
| Correlation between Log (IL-1B)-Log (IL6) |
|
| Correlation between Log (IL-1B)-Log (TNF-a) |
|
| Correlation between Log (IL6)-Log (TNF-a) |
|
| Fatigue |
|
| Pain |
|
| Sleep |
|
|
| Correlation between Anxiety-Sleep |
|
| Correlation between Depression-Fatigue |
|
| Correlation between Depression-Pain |
|
| Correlation between Depression-Sleep |
|
| Correlation between Fatigue-Pain |
|
| Correlation between Fatigue-Sleep |
|
| Correlation between Pain-Sleep |
|
| Log (IL6) |
|
| Log (TNF-a) |
|
| Title | Measurements |
|---|
|
| Correlation between Log (IL-1B)-Log (IL6) |
|
| Correlation between Log (IL-1B)-Log (TNF-a) |
|
| Correlation between Log (IL6)-Log (TNF-a) |
|
| Fatigue |
|
| Pain |
|
| Sleep |
|
|
| Correlation between Anxiety-Sleep |
|
| Correlation between Depression-Fatigue |
|
| Correlation between Depression-Pain |
|
| Correlation between Depression-Sleep |
|
| Correlation between Fatigue-Pain |
|
| Correlation between Fatigue-Sleep |
|
| Correlation between Pain-Sleep |
|