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

• 批准号: 8496726
• 负责人: DAWN HERSHMAN
• 金额: $ 50.83万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 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/8496726
• 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

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在改善疾病的生存期，降低远处和局部复发率以及早期乳腺癌受体阳性乳腺癌的女性中相互抗乳腺癌的入围率降低，降低远处和局部复发率以及降低相反的乳腺癌的入射。然而，多达50％的女性在AI上报告了肌肉骨骼疼痛和关节关节痛的症状，这可能导致不符合性和早期中断，从而影响生存。我们以前的II期随机研究（n = 40）表明，每周两次给药6周的针灸与假针刺相比改善了AI诱导的关节疼痛/僵硬，这是通过修改后的短暂疼痛指数短形式（MBPI-SF）测得的疼痛评分，疼痛评分降低了50％。拟议的SWOG III期随机，假手术，盲目的，以上为中心的临床试验将研究针灸对228名I-III II II期乳腺癌女性AI的启动或增加的关节疼痛/僵硬的影响。妇女将从四个机构中招募，并随机分配到每周两次进行一次针灸或假针刺，持续6周，每周进行一次针灸或假针刺6周或候补名单控制组。真正的针灸会话将包括标准化的全身和特定点处方和NADA耳孔方案。假针灸治疗将包括在全身和与任何真正针灸点相对应的联合特定点处方的表面针刺组成。主要的假设是，与假针刺相比，通过MBPI-SF分数测量，每周两次施用每周两次，每周两次，然后每周6周，将减少AI诱导的节肢动物的关节疼痛/僵硬。次要终点将评估从第6周到第12周的每周维护真正的针灸，将维持第6周的效果，如MBPI-SF在12周时测得的效果，以及与Sham Axmuncture相比。 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骨关节炎研究协会国际标准（Omeract-OARSI），2）通过自我管理的问卷调查评估癌症疗法的功能评估癌症疗法 - 尿布/内分泌子量表（Fact-b/es），3）止痛药的功能评估，4）功能性测试（抓手力量和较低的极端疾病），以及5）探索性的5） AI依从性。这项研究将是第一个大型多中心干预试验，研究针灸对AI诱导的关节疾病对乳腺癌女性的影响。