Effect of Acupuncture vs Chinese Medicine vs Combined Therapy on Aromatase Inhibitor-related Arthralgia Among Women With Early-Stage Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory-Worst Pain Item (BFI-WP)
研究概览
简要总结
Aromatase inhibitors have been used to treat hormone receptor positive breast cancer women in menopause, but side effects, such as joint pain, would affect their qualities of life. Chinese herbs or acupuncture provides promising clinical effects and plays an important role on alleviating the side effects of cancer treatment. This clinical trial will evaluate the effect of the acupuncture, Chinese medicine, and the combination of both on joint pain related to aromatase inhibitors among women with early-stage breast cancers.
详细描述
Reduce estrogen exposure can lower the risk of breast cancer recurrence. Aromatase inhibitors have been used to treat hormone receptor positive breast cancer women in menopause for years. It can increase the survival rate and decrease the chance of recurrence. However, many patients suffered from the side effects of medication, including joint pain, is the main reason for decreasing medication adherence and influencing patients' quality of life. Based on previous phase III clinical trial study, acupuncture may relieve aromatase inhibitor associated joint pain, and experts believe that acupuncture could also be considered as an effective adjuvant treatment. Chinese herbs or acupuncture provides promising clinical effects and plays an important role in alleviating the side effects of cancer treatment. Guizhi-Shaoyao-Zhimu decoction has frequently being prescribed to treat joint pain in traditional Chinese medicine practice. The design of this clinical trial will evaluate the effects of the acupuncture, Chinese medicine, and the combination of both on joint pain related to aromatase inhibitors among women with early-stage breast cancer. The goal of this study was to evaluate the efficacy and safety with regards to utilizing acupuncture and Chinese herbs in treating joint pain related to the usage of aromatase inhibitors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with diagnosis of early breast cancer (stages I-III), expressing hormone receptor-positive (ER+, PR+, or both) and took third generation aromatase inhibitors (AIs).
- •Post- or pre-menopausal with the use of a gonadotropin-releasing hormone agonist.
- •Taking AIs for more than 30 days before registration and planned to continue treatment for over 1 year.
- •Have already been recovered from the surgery or chemotherapy.
- •Have a ECOG performance status score of 0 to
- •Joint pain which has developed or worsened since starting AIs therapy. The worst pain item score of Brief Pain Inventory-Short Form (BPI-SF) is at least 3 and above.
- •Have a Eastern Cooperative Oncology Group (ECOG) grading scale for chemotherapy-induced peripheral neuropathy score of 1 to
- •The patient could cooperate the intervention and sign the informed consent.
排除标准
- •Had received acupuncture treatment for joint pain would be excluded, but patients with acupuncture treatment for less than 2 times due to other reasons could be included.
- •Had a history of fractures or underwent surgery on the knee or hand joints in the past six months.
- •Had severe bleeding disorders. The platelet counts are below 50,000 per μl.
- •Cognitive disorders (included dementia).
- •Lymphedema after breast cancer surgery.
研究组 & 干预措施
acupuncture group
Stainless steel, disposable, sterile needles choosing based on the needs of different body parts (0.22 gauge x 25mm, 0.22 gauge x 40mm, or 0.25 gauge x 100mm) were inserted to acupoints at traditional depths and angles.
干预措施: acupuncture (Device)
Chinese medicine group
The Chinese medicine group used Guizhi-Shaoyao-Zhimu decoction (GZSD) as their medical intervention. The GZSD samples were made and packed by Sun Ten Pharmaceutical Co. Ltd., a firm that meets the requirements of the good manufacturing practice (GMP) certification in Taiwan. Every 4g of concentrated GZSD was sealed in an isolated paper drug bag.
干预措施: Guizhi-Shaoyao-Zhimu decoction (Drug)
combined group
The combined group would have both acupuncture and Chinese medicine interventions.
干预措施: acupuncture (Device)
combined group
The combined group would have both acupuncture and Chinese medicine interventions.
干预措施: Guizhi-Shaoyao-Zhimu decoction (Drug)
结局指标
主要结局
Brief Pain Inventory-Worst Pain Item (BFI-WP)
时间窗: Change from baseline at 6 weeks
a 0- to 10-point scale (0 \[no pain\] to 10 \[pain as bad as you can imagine)
次要结局
- Brief Pain Inventory - Short Form (BPI-SF)(Change from baseline at 6 weeks)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Change from baseline at 6 weeks)
- Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH)(Change from baseline at 6 weeks)
- Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)(Change from baseline at 6 weeks)
研究者
Lee I-Ting
doctor
Show Chwan Memorial Hospital