Breast Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREAcupuncture Therapy
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.
Sponsors
Saint John's Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female * Must be on aromatase inhibitor therapy continuously for breast cancer treatment for at least the preceding two months * Must have experienced increased or new onset joint pain daily to a degree equal to or greater than 4 on a pain scale of 0-10 after starting aromatase inhibitor therapy * Able to read and write English * Able to give written informed consent to participate in the study
Exclusion criteria
* Have a known autoimmune disease or acute infection * Have had acupuncture treatment within 6 months of study enrollment * Known needle phobia * Known metal allergies * Have an implantable device, such as pacemaker, defibrillator or other device contraindicated with electrical stimulation * Use of nonsteroidal antiinflammatory drugs (NSAIDs) or narcotics within 7 days of study enrollment and during study period (15 weeks) * Receipt of prior chemotherapy, immunotherapy or radiation therapy within 90 days * On anticoagulant therapy * Receiving physical or occupational therapy concurrently * Taking herbs or herbal teas within 7 days of study enrollment and during study period (15 weeks) * Have an immune-compromising medical condition or currently receiving immune-modulating therapies (including corticosteroids) * Enrolled in any other active cancer treatment protocols * Bone fracture or surgery of an affected extremity within 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Joint Pain tabulated from Joint Pain Assessment Questionnaire | 3 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adaptive immune response as measured by cytokine levels | 3 years | Investigators will collect prospective blood samples to test for for cytokine levels |
| Innate immune response as measured by cytokime levels | 3 years | Investigators will collect prospective blood samples to test for cytokine levels |
Countries
United States
Outcome results
None listed