Acupuncture for Aromatase Inhibitor-Related Arthralgias in Breast Cancer Patients

针灸治疗乳腺癌患者芳香酶抑制剂相关的关节痛

基本信息

批准号：
8320010
负责人：
DAWN HERSHMAN
金额：
$ 52.52万
依托单位：
COLUMBIA UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-01 至 2016-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8320010
关键词：
Acupuncture Points Acupuncture procedure Adherence Adverse effects Analgesics Aromatase Aromatase Inhibitors Arthralgia Biological Markers Blinded Breast Brief Pain Inventory CYP19A1 gene Cancer Patient Cancer Survivor Chronic Clinical Trials Controlled Study Cyclophosphamide Degenerative polyarthritis Diagnosis Disease-Free Survival Distant Endocrine Estradiol Evaluation Generations Genes Genetic Polymorphism Hand Hip region structure Hormone Receptor Hormones Incidence Inflammatory Institution Interleukin-12 Interleukin-6 International Intervention Trial Joints Knee Lateral Lead Life Long-Term Effects Lower Extremity Maintenance Measures Multi-Institutional Clinical Trial Musculoskeletal Pain Needles Ontario Opioid Analgesics Outcome Measure Pain Patient Self-Report Phase Population Study Protocols documentation Quality of life Quality-of-Life Assessment Questionnaires Randomized Recruitment Activity Recurrence Reporting Research Rheumatology Safety Self-Administered Serum Severities Societies Southwest Oncology Group Staging Survivors Symptoms Tamoxifen Testing Time Universities Urine Waiting Lists Woman affection arm cancer therapy functional status grasp improved indexing malignant breast neoplasm non-compliance pilot trial response

项目摘要

Third generation aromatase inhibitors have been shown to be superior to tamoxifen in improving disease free survival, decreasing distant and local recurrence rates and decreasing incidence of contra-lateral breast cancer in women with early stage hormone receptor positive breast cancer. However, up to 50% of women on AI report symptoms of debilitating musculoskeletal pain and joint arthralgia that can lead to noncompliance and early discontinuation, thereby impacting survival. Our previous phase II randomized study (n=40) showed that acupuncture administered twice weekly for 6 weeks compare to sham acupuncture improve AI induced joint pain/stiffness as measured by modified Brief Pain Index short form (mBPI-sf) worse pain score by 50%. The proposed SWOG phase III randomized, sham controlled, blinded, multi-centered clinical trial will look at the effects of acupuncture on joint pain/stiffness that started or increased since initiation of AI in 228 women with Stage I-III breast cancer. Women will be recruited from four institutions and randomized to either true acupuncture or sham acupuncture administered twice weekly for 6 weeks follow by maintenance weekly acupuncture or sham acupuncture for 6 weeks or to a wait list control arm. True acupuncture sessions will consists of standardized full body and joint specific point prescription and the NADA auricular protocol. The sham acupuncture treatment will consist of superficial needling at full body and joint specific point prescriptions that do not correspond to any true acupuncture points. The primary hypothesis is that acupuncture administered twice weekly for 6 weeks then weekly for 6 weeks will reduce joint pain/stiffness in women with AI induced arthragia as measured by mBPI-SF scores at 6 weeks compared to sham acupuncture. Secondary endpoints will assess whether weekly maintenance true acupuncture from week 6 to week 12 will maintain the effects seen at week 6 as measured by mBPI-SF score at 12 weeks and whether true acupuncture will have a durable effect as measure by mBPI-SF score at 24 and 52 weeks, compared to sham acupuncture. Other secondary endpoint (to be evaluated at baseline, 6, 12, 24 and 52 weeks) include 1) additional assessment of joint pain/stiffness and functional status via self administered questionnaires (Western Ontario and McMaster Universities Osteoarthritis (WOMAC), Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) and Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International criteria (OMERACT-OARSI), 2) quality of life assessment via the self administered questionnaire Functional Assessment of Cancer Therapy-Breast/Endocrine subscale (FACT-B/ES), 3) analgesic use, 4) functional testing (grip strength and ¿timed get up and go¿ for lower extremity¿) and 5) exploratory inflammatory biomarkers and urine markers for AI adherence. This study will be the first large multi-center center intervention trial looking at the effects of acupuncture on AI induced arthragia in women with breast cancer.

第三代芳香酶抑制剂已被证明在改善早期激素受体阳性乳腺癌女性的无病生存率、降低远处和局部复发率以及降低对侧乳腺癌发生率方面优于他莫昔芬，但高达 50%。接受 AI 治疗的女性报告出现肌肉骨骼疼痛和关节痛的症状，这些症状可能导致不依从和提前停药，从而影响生存。我们之前的 II 期随机研究 (n=40) 表明，与假针灸相比，连续 6 周每周两次的针灸改善了 AI 引起的关节疼痛/僵硬（通过改良的简短疼痛指数简表 (mBPI-sf) 测量），所提出的 SWOG III 期随机、假手术对照、盲法改善了 50% 的疼痛评分。一项多中心临床试验将研究针灸对 228 名 I-III 期乳腺癌女性自 AI 开始后开始或加剧的关节疼痛/僵硬的影响。从四家机构招募，随机接受真针灸或假针灸，每周两次，持续 6 周，然后每周进行维持针灸或假针灸，持续 6 周，或等待名单上的真针灸疗程将包括标准化的全身和关节。特定穴位处方和 NADA 耳穴方案假针灸治疗将包括全身浅刺和关节特定穴位处方，与任何真正的针灸不对应。主要假设是，与假针灸相比，针灸每周两次，持续 6 周，然后每周进行 6 周，将减轻 AI 诱发关节痛的女性的关节疼痛/僵硬（通过 6 周时的 mBPI-SF 评分进行测量）。从第 6 周到第 12 周每周维持真针灸是否会维持第 6 周所见的效果（根据第 12 周时的 mBPI-SF 评分来衡量）以及真针灸是否会维持与假针灸相比，在 24 周和 52 周时通过 mBPI-SF 评分衡量，具有持久效果。其他次要终点（在基线、6、12、24 和 52 周进行评估）包括 1) 关节疼痛/的额外评估。通过自我管理问卷调查僵硬和功能状态（西安大略大学和麦克马斯特大学骨关节炎 (WOMAC)，慢性骨关节炎评估和量化的改良评分手部类风湿病 (M-SACRAH) 和风湿病临床试验和骨关节炎研究协会国际标准 (OMERACT-OARSI) 的结果测量，2) 通过自填问卷进行生活质量评估癌症治疗功能评估 - 乳腺癌/内分泌分量表(FACT-B/ES), 3) 镇痛药的使用，4) 功能测试（握力和 ¿定时起床并离开¿对于下肢¿ ）和 5）探索 AI 依从性的炎症生物标志物和尿液标志物这项研究将是第一个大型多中心干预试验，旨在研究针灸对乳腺癌女性 AI 引起的关节炎的影响。