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Researchers at the John Wayne Cancer Institute (JWCI) at Providence Saint John's Health Center (PSJHC) are trying to examine whether acupuncture reduces joint pain in patients being treated with aromatase inhibitor (AI) therapy for breast cancer and whether the reduction in pain happens by lowering inflammation.
The investigators propose to investigate the effect of acupuncture on patients experiencing joint pain from aromatase inhibitor therapy. The investigators will serially measure patient's symptoms and track current medications, joint pain, daily activities, fatigue, and quality of life. The investigators will collect peripheral blood at baseline, weeks 4 and 7, one week after the last acupuncture treatment and 4 weeks after the last acupuncture treatment. The investigators will study the samples collected at the five predetermined time-points to test for immune parameters, such as the innate and adaptive immune responses, as well as the proliferative capabilities and pro-inflammatory mediators reflected in innate and adaptive functional immune responses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture Therapy | Experimental | Based on the Traditional Chinese Medicine theory, investigators will use the systemic treatment methods (full body treatment with the joint specifications). Every patient will receive the standard protocols of these points uniformly regardless of their symptoms. The only variable will be the location of placement of the four electrodes (two positive charges and two negative charges) to the needle points at the most painful joints bilaterally. Needles will be in place a total of 45 minutes per session. The Thermal Design Power (TDP) infrared heat lamp will be applied concurrently to the most painful joint(s) for the entire 45 minutes. Acupuncture will be administered twice a week for 6 weeks, then once a week for an additional 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture Therapy | Procedure | The standard textbook of Chinese Acupuncture and Moxibustion is the source for the name and location of the points for this study. A total of 38 points will be used, divided between two acupuncture sessions: 20 points or 37 locations in the supine position; 18 points or 36 locations in the prone position. Other than points governing vessel (GV) 20, conception vessel (CV) 6, CV 10, all points will be performed bilaterally. |
| Measure | Description | Time Frame |
|---|---|---|
| Joint Pain tabulated from Joint Pain Assessment Questionnaire | Investigators will serially measure joint pain symptoms using questionnaires administered at pre-determined time points. A summary of pain scores will be tabulated for all visits. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adaptive immune response as measured by cytokine levels | Investigators will collect prospective blood samples to test for for cytokine levels | 3 years |
| Innate immune response as measured by cytokime levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Crane-Okada, MD | Saint John's Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Wayne Cancer Institute | Santa Monica | California | 90404 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Investigators will collect prospective blood samples to test for cytokine levels
| 3 years |
| D017437 |
| Skin and Connective Tissue Diseases |