Randomized, double-blinded, placebo-controlled trial of traditional Chinese Medicine for the management of aromatase inhibitor-associated musculoskeletal symptoms

Beijing Municipal Science and Technology Commission (China)0 个研究点目标入组 84 人开始时间: 2013年8月14日最近更新: 2017年11月20日

试验速览

暂无简介。

•1. Stage I-III breast cancer with no evidence of recurrence and metastasis, completed chemotherapy and/or radiotherapy
•2. Use of a third-generation aromatase inhibitor (AI) and self-report ongoing musculoskeletal symptoms after initiation of aromatase inhibitor (AI) therapy
•3. A baseline worst pain score over the past week on the Brief Pain Inventory-Short Form (BPI-SF) of =3 points on a scale of 0 to 10
•4. Traditional Chinese Medicine (TCM) syndrome is differentiated as deficiency of liver and kidney, qi and collaterals stagnation
•5. Anticipated survival time is more than six months
•6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
•7. All patients provided written informed consent before enrollment

•1. Patients with endocrine and any other diseases influencing bone metabolism (hyperthyroidism, hypothyroidism, diabetes, chusing syndrome, chronic liver disease, nephropathy, myeloma, bone tumor, bone metastasis)
•2. Use of the agents influencing bone metabolism (glucocorticoid, thyroid hormone, heparin, anticonvulsant, diuretic, bisphosphonates) except calcium within the past three months
•3. Contraindication in calcium agent and vitamin D
•4. Diagnosis of primary osteoarticular diseases
•5. Complicated with other primary tumors and serious heart, liver, kidney and hematopoietic system diseases
•6. Pregnancy, mental illness and cognitive handicap

发起方

Beijing Municipal Science and Technology Commission (China)