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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00792 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2015-0750 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| Gateway for Cancer Research | OTHER |
| National Cancer Institute (NCI) | NIH |
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This randomized phase II trial studies how well electroacupuncture therapy works in reducing chronic pain in patients following surgery for stage I-III breast cancer. Electroacupuncture therapy is a type of complementary integrative medicine in which pulses of weak electrical current are sent through very thin, solid, sterile, stainless steel needles into certain points in the skin. Electroacupuncture therapy may help to lower pain and other surgery-related symptoms.
PRIMARY OBJECTIVE:
I. Determine the initial efficacy of electroacupuncture (EA) in reducing chronic pain in women following treatment for breast cancer.
SECONDARY OBJECTIVES:
I. Determine if EA produces greater improvement in physical functional mobility as compared to sham electroacupuncture (SEA) or waitlist control (WLC)s.
II. Determine if EA produces greater improvement in overall quality of life (QOL) and symptoms related to fatigue, sleep and mood disturbance compared to SEA or WLC.
III. Determine if EA produces lower pain vigilance and awareness as compared to SEA or WLC.
IV. Examine the association between baseline expectancy and outcomes. V. Explore associations between response to acupuncture and biologic measures, including 1) single nucleotide polymorphisms (SNPS) in catechol-O- methyltransferase (COMT) and opioid receptor-mu1 (OPRM1), and 2) autotaxin (ATX)/lysophosphatidic acid (LPA) axis.
VI. Explore if EA reduces emotional, financial, and behavioral concerns among patients and caregivers compared to the SEA or WLC.
OUTLINE: Patients are randomized to 1 of 3 groups.
GROUP I (EA): Patients undergo electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions.
GROUP II (SEA): Patients undergo modified electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions. Acupuncture needles are placed in different locations using a different technique than those used for Group I.
GROUP III (WLC): Patients receive standard of care without any kind of acupuncture therapy.
After completion of study treatment, patients are followed up at 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (electroacupuncture therapy) | Experimental | Patients undergo electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions. |
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| Group II (sham electroacupuncture therapy) | Placebo Comparator | Patients undergo modified electroacupuncture therapy over 45 minutes 2-3 times per week over 4 weeks for a total of 10 sessions. Acupuncture needles are placed in different locations using a different technique than those used for Group I. |
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| Group III (waitlist control) | Active Comparator | Patients receive standard of care without any kind of acupuncture therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroacupuncture Therapy | Procedure | Undergo electroacupuncture therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in pain scores assessed by Brief Pain Inventory (BPI) | Change in pain scores will be compared between groups. Assessing the initial efficacy of electroacupuncture (EA) relative to sham electroacupuncture (SEA) and waitlist control (WLC), use linear regression and linear mixed model analyses. Pain Scores(0-10) 0 No pain-10 Worst Pain. | Baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of single nucleotide polymorphisms (SNPs) in (COMT) catechol-O- methyltransferase | Will explore the correlations between response to acupuncture and presence of different gene variations in (COMT) catechol-O- methyltransferase and (OPRM1). Will use linear regression and linear mixed model analyses. | Up to 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Cohen | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| Electroacupuncture Therapy | Procedure | Undergo modified electroacupuncture therapy |
|
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Presence of single nucleotide polymorphisms (SNPs) in (OPRM1) opioid receptor-mu1 |
Will explore correlations between response to acupuncture and presence of different gene variations in (COMT) catechol-O- methyltransferase and (OPRM1) opioid receptor-mu1. Will use linear regression and linear mixed model analyses. |
| Up to 8 weeks |
| Change in autotaxin (ATX)/lysophosphatidic acid (LPA) axis | Will explore correlations between response to acupuncture and ATX-mediated LPA biosynthesis. Will use linear regression and linear mixed model analyses. | Baseline to 8 weeks |
| Spouse Behavior Subscale of the Multidimensional Pain Inventory (SBS-MPI) Questionnaire | Emotional, financial, and behavioral concerns among patients and caregivers will be compared between (EA) electroacupuncture and (SEA) sham electroacupuncture or (WLC) waitlist control group. (Agree or Disagree 5-1) 1-Strongly Disagree, 2-Disagree, 3-Neither agree or Disagree, 4-Agree 5-Strongly Agree | Up to 8 weeks |
| Caregiver Reaction Assessment (CRA) Questionnaire | Emotional, financial, and behavioral concerns among patients and caregivers will be compared between (EA) electroacupuncture and (SEA) sham electroacupuncture or (WLC) waitlist control group. (Agree or Disagree 5-1) 1-Strongly Disagree, 2-Disagree, 3-Neither agree or Disagree, 4-Agree 5-Strongly Agree | Up to 8 weeks |
| Baseline expectancy of participants will be correlated to the outcomes response. | Will use linear regression and linear mixed model analyses. | At baseline |
| Physical functional mobility will be compared. | Change in physical functional mobility will be compared between groups. Assessing the initial efficacy of (EA) electroacupuncture relative to (SEA) sham electroacupuncture and (WLC) waitlist control group., use linear regression and linear mixed model analyses. | Baseline to 8 weeks |
| Quality of life (QOL) questionnaire | Change in overall (QOL) Quality of life will be compared between groups. Assessing the initial efficacy of (EA) electroacupuncture relative to (SEA) sham electroacupuncture and (WLC) waitlist control group., use linear regression and linear mixed model analyses. | Baseline to 8 weeks |
| Changes in symptoms of fatigue questionnaire | Changes in symptoms of fatigue, sleep, and mood disturbance will be compared between groups. Assessing the initial efficacy of (EA) electroacupuncture (SEA) sham electroacupuncture and (WLC) waitlist control group., use linear regression and linear mixed mode Fatigue (0-10) 0 No Fatigue-10 Fatigue | Baseline to 8 weeks |
| Changes in symptoms of sleep questionnaire | Changes in symptoms of fatigue, sleep, and mood disturbance will be compared between groups. Assessing the initial efficacy of (EA) electroacupuncture (SEA) sham electroacupuncture and (WLC) waitlist control group., use linear regression and linear mixed mode. Thee Pittsburgh Sleep Quality Index (PSQI) Very Good (0) Fairly Good (1) Fairly Bad(2) Very Bad (3) | Baseline to 8 weeks |
| Changes in symptoms of mood disturbance | Changes in symptoms of fatigue, sleep, and mood disturbance will be compared between groups. Assessing the initial efficacy of (EA) electroacupuncture (SEA) sham electroacupuncture and (WLC) waitlist control group., use linear regression and linear mixed mode. Mood (0-10) 0 Does not interfere, 10 Completely Interferes. | Baseline to 8 weeks |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
| D004599 | Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |
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