Clinical trial NCT02548637: Effects of Acupuncture on Aromatase Inhibitor-Induced Joint Pain
Official title: Effects of Acupuncture on Aromatase Inhibitor-Induced Joint Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Saint John's Cancer Institute
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Joint Pain tabulated from Joint Pain Assessment Questionnaire
timeFrame: 3 years
Secondary outcomes:
measure: Adaptive immune response as measured by cytokine levels
timeFrame: 3 years
measure: Innate immune response as measured by cytokime levels
timeFrame: 3 years
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: John Wayne Cancer Institute
state: California
Study officials:
affiliation: Saint John's Cancer Institute
name: Rebecca Crane-Okada, MD
role: PRINCIPAL_INVESTIGATOR
References: