Safety, effectiveness, and economic evaluation of adjuvant moxibustion therapy for aromataseinhibitor (AI)-induced arthralgia of postmenopausal breast cancer stage ?–? patients: a prospective, randomized, assessor-blind, usual-care controlled, parallel-group, pilot clinical trial

Kyung Hee University0 个研究点目标入组 46 人开始时间: 待定最近更新: 2019年5月20日

试验速览

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•1) Female, aged 45 to 65, who have missed menstrual periods in a row for at least 1 year (amenorrhea) or is showing 45mIU/mL or higher of serum follicle-stimulating hormone
•2) Estrogen receptor positive breast cancer patients of stage I to III, who have completed surgical procedures, chemotherapy, and/or radiation therapy and planned no more active treatments
•3) Patients who have been taking the 3rd generation aromatase inhibitors (anastrozole, letrozole, etc.) for 3 months or more and plan to continue the oral administration while participating in this study
•4) Patients who are complaining arthralgia in one or more joints, newly developed after the administration of the aromatase inhibitors
•5) 4 points or higher of the maximum pain level, assessed with Brief Pain Inventory-Short Form at screening assessment
•6) Volunteers who signed the informed consent forms

•1) Primary/metastatic residual cancer or recurrent cancer
•2) History of fracture or surgery in the joints where the pain exists within 3 months
•3) History of moxibustion therapy in the joints with aromatase inhibitor-induced arthralgia within 3 months
•4) Present administration of steroid/narcotic analgesics
•5) History of allergy to moxibustion or keloid, presence of skin diseases on body parts for moxibustion therapy
•6) Refusal to therapy due to moxibustion fear
•7) Participation in another clinical study within 1 month
•8) Any other inappropriate reasons to participate in the study, judged by the investigators

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