Anxiety DisorderPhase 3NCT00902330
Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer
A Phase 3 study testing energy-based therapy in people with Anxiety Disorder and Breast Cancer, run by Virginia Commonwealth University.
Trial summary
RATIONALE: Cranial microcurrent electrical stimulation (CES) is mild electrical current received through electrodes placed on the earlobes. CES may lessen symptoms in women with breast cancer receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety Disorder, Breast Cancer, Depression
- What is being tested?
- energy-based therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to May 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of stage I-IIIA breast cancer
- Scheduled to receive adjuvant chemotherapy
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Pre, peri, or post-menopausal
- ECOG performance status 0-1
- No dementia
- No active psychosis
- No history of seizure disorder
- No implanted electrical device
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy
- No initiation of a medication regimen for depression or other psychiatric condition within the past 30 days
About this study
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.
Read the detailed description
OBJECTIVES:
Primary
- To compare the effects of cranial microcurrent electrical stimulation (CES) vs sham CES over time on symptoms of depression, anxiety, fatigue, pain, and sleep disturbances in women with stage I-IIIA breast cancer receiving adjuvant chemotherapy.
Secondary
- To explore the relationships among selected markers of inflammation (e.g., tumor necrosis factor alpha, interleukin-6, interleukin-1β, and C-reactive protein), symptoms, and quality of life.
- To examine whether the symptoms of depression, anxiety, fatigue, sleep disturbances, and pain form a cluster.
- To examine the effects of CES on quality of life.
OUTLINE: Patients are stratified according to chemotherapy schedule (every 2 weeks for 8 courses vs every 3 weeks for 6 courses). Patients are randomized to 1 of 2 treatment arms.
- Arm I (cranial microcurrent electrical stimulation [CES]): Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.
- Arm II (sham CES): Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.
Patients complete symptom questionnaires (e.g., the Hospital Anxiety and Depression Scale, the Brief Pain Inventory Short-Form, the Brief Fatigue Inventory, and the General Sleep Disturbance Scale) weekly in weeks 1-18. Patients also complete a quality-of-life questionnaire in weeks 1, 7, and 18.
Blood samples are collected in weeks 1, 7, and 18 and analyzed for cytokines (e.g., tumor necrosis factor alpha, interleukin-6, and interleukin-1β) and C-reactive protein.
- Conditions
- Anxiety Disorder, Breast Cancer, Depression, Fatigue, Pain, Sleep Disorders
- Being tested
- energy-based therapy, sham intervention
- Keywords
- depression, anxiety disorder, fatigue, pain, sleep disorders, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
- Medical subject headings
- Anxiety Disorders, Breast Neoplasms, Depression, Fatigue, Pain, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
energy-based therapyProcedure or surgery
Given once a day for 18 weeks
sham interventionProcedure or surgery
Given once a day for 18 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: energy-based therapy |
| 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. Receives: Procedure: sham intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 2 weeks afer completion of study treatment, for up to 8 months
Secondary outcomes (19)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy
Simple correlations will be computed at Baseline Chemotherapy for symptoms.
Measured: 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.
Measured: Baseline
Relationships Among Quality of Life Scores - Correlations at Baseline
Simple correlations will be computed at Baseline for quality of life scores.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Midpoint Chemotherapy, up to 4 months
Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy
Simple correlations will be computed at Midpoint Chemotherapy for symptoms.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 weeks afer completion of study treatment, for up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Deborah McGuire, PhD,RN,FAAN, Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902330
- Sponsor's protocol ID
- MCC-11995
- Other IDs
- HM11995, CDR0000641994, NCI-2011-00234
- Status last verified
- Nov 2015
- First submitted
- 14 May 2009
- Last updated
- 23 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 26435889
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer
- ClinicalTrials.gov ID
- NCT00902330
- Acronym / sponsor ID
- MCC-11995
- Conditions
- Anxiety Disorder, Breast Cancer, Depression, Fatigue, Pain, Sleep Disorders
- Keywords
- depression, anxiety disorder, fatigue, pain, sleep disorders, stage IA breast cancer, stage IB breast cancer, stage II breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 15 May 2009 (estimated)
- Results
- Posted 2 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Cranial microcurrent electrical stimulation (CES) is mild electrical current received through electrodes placed on the earlobes. CES may lessen symptoms in women with breast cancer receiving chemotherapy. It is not yet known whether CES is more effective than sham therapy in reducing symptoms caused by chemotherapy in women with breast cancer.
PURPOSE: This randomized phase III trial is studying mild electrical stimulation to see how well it works compared with sham therapy in reducing symptoms caused by chemotherapy in women with stage I, stage II, or stage IIIA breast cancer receiving chemotherapy.
Detailed description
OBJECTIVES:
Primary
- To compare the effects of cranial microcurrent electrical stimulation (CES) vs sham CES over time on symptoms of depression, anxiety, fatigue, pain, and sleep disturbances in women with stage I-IIIA breast cancer receiving adjuvant chemotherapy.
Secondary
- To explore the relationships among selected markers of inflammation (e.g., tumor necrosis factor alpha, interleukin-6, interleukin-1β, and C-reactive protein), symptoms, and quality of life.
- To examine whether the symptoms of depression, anxiety, fatigue, sleep disturbances, and pain form a cluster.
- To examine the effects of CES on quality of life.
OUTLINE: Patients are stratified according to chemotherapy schedule (every 2 weeks for 8 courses vs every 3 weeks for 6 courses). Patients are randomized to 1 of 2 treatment arms.
- Arm I (cranial microcurrent electrical stimulation [CES]): Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.
- Arm II (sham CES): Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.
Patients complete symptom questionnaires (e.g., the Hospital Anxiety and Depression Scale, the Brief Pain Inventory Short-Form, the Brief Fatigue Inventory, and the General Sleep Disturbance Scale) weekly in weeks 1-18. Patients also complete a quality-of-life questionnaire in weeks 1, 7, and 18.
Blood samples are collected in weeks 1, 7, and 18 and analyzed for cytokines (e.g., tumor necrosis factor alpha, interleukin-6, and interleukin-1β) and C-reactive protein.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (cranial microcurrent electrical stimulation [CES]) | Experimental | Procedure: energy-based therapyPatients 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 | Procedure: sham interventionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| energy-based therapyGiven once a day for 18 weeks | Procedure or surgery | Arm I (cranial microcurrent electrical stimulation [CES]) |
| sham interventionGiven once a day for 18 weeks | Procedure or surgery | Arm II (sham CES) |
Primary outcome
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
Time frame: Up to 2 weeks afer completion of study treatment, for up to 8 months
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
19 secondary outcomes
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Time frame: 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).
Time frame: Baseline
Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).
Time frame: Baseline
Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline
Time frame: Baseline
Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy
Time frame: Baseline
Relationships Among Quality of Life Scores - Means at Baseline
Time frame: Baseline
Relationships Among Quality of Life Scores - Correlations at Baseline
Time frame: 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).
Time frame: Midpoint Chemotherapy, up to 4 months
Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy
Time frame: Midpoint Chemotherapy, up to 4 months
Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy
Time frame: Midpoint Chemotherapy, up to 4 months
Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy
Time frame: Midpoint Chemotherapy, up to 4 months
Relationships Among Quality of Life Scores - Means at Midpoint Chemotherapy
Time frame: Midpoint Chemotherapy, up to 4 months
Relationships Among Quality of Life Scores - Correlations at Midpoint Chemotherapy
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: Up to 2 weeks afer completion of study treatment, for up to 8 months
Relationships Among Symptom Scores - Correlations at End of Chemotherapy
Time frame: 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
Time frame: 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
Time frame: Up to 2 weeks afer completion of study treatment, for up to 8 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26435889Lyon 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah McGuire, PhD,RN,FAAN principal investigator
Massey Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing energy-based therapy in people with Anxiety Disorder and Breast Cancer, run by Virginia Commonwealth University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer (time frame: Up to 2 weeks afer completion of study treatment, for up to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00902330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2015.