Breast Cancer Clinical Trial

Effects of Acupuncture on Aromatase Inhibitor-Induced Joint Pain

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.

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Full 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.

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Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

20

Study ID:

NCT02548637

Recruitment Status:

Completed

Sponsor:

Saint John's Cancer Institute

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There is 1 Location for this study

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John Wayne Cancer Institute
Santa Monica California, 90404, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

20

Study ID:

NCT02548637

Recruitment Status:

Completed

Sponsor:


Saint John's Cancer Institute

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