Effects of Acupuncture on Aromatase Inhibitor-Induced Joint Pain



Status:Recruiting
Conditions:Breast Cancer, Cancer, Orthopedic
Therapuetic Areas:Oncology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:4/22/2017
Start Date:June 2015
End Date:March 2018
Contact:Rebecca Crane-Okada
Email:Rebecca.Crane-Okada@providence.org

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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.

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
We found this trial at
1
site
2200 Santa Monica Blvd
Santa Monica, California 90404
(310) 582-7438
Principal Investigator: Rebecca Crane-Okada, Ph.D.
Phone: 310-582-7138
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mi
from
Santa Monica, CA
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