Effects of Acupuncture on Aromatase Inhibitor-Induced Joint Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Joint Pain tabulated from Joint Pain Assessment Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Acupuncture Therapy
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.
干预措施: Acupuncture Therapy (Procedure)
结局指标
主要结局
Joint Pain tabulated from Joint Pain Assessment Questionnaire
时间窗: 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.
次要结局
- Innate immune response as measured by cytokime levels(3 years)
- Adaptive immune response as measured by cytokine levels(3 years)