Pharmacopuncture for Aromatase Inhibitor Induced Arthralgia (AIA) on Effectiveness, Safety, and Cost-Effectiveness in Patients With Breast Cancer : An Open-Label, Assessor-Blinded, Pragmatic Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Change in Brief pain inventory-Korean version (BPI-K)
研究概览
简要总结
This is a pragmatic pilot trial designed to compare and evaluate the efficacy, safety, and cost-effectiveness of pharmacopuncture treatment versus a control group in aromatase inhibitor-induced arthralgia patients with breast cancer.
详细描述
This is a pragmatic clinical study designed to compare and evaluate the efficacy, safety, and cost-effectiveness of pharmacopuncture treatment versus a control group in breast cancer patients (aged 19-75) suffering from aromatase inhibitor (AI)-induced arthralgia.
Aromatase inhibitors are required for a significant number of patients with hormone-receptor-positive breast cancer, and it is known that 50-96% of these patients experience associated arthralgia. While acupuncture is known to be effective for this condition, the efficacy of pharmacopuncture remains unknown; therefore, this study aims to investigate the utility of pharmacopuncture for AI-induced arthralgia.
If assigned to the control group, you will receive necessary analgesics-such as acetaminophen, NSAIDs, tramadol, analgesics for rheumatoid arthritis, or neuropathic pain medications-based on the clinician's judgement. If assigned to the treatment group, you will receive pharmacopuncture treatment in addition to the aforementioned conventional medications.
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 19 to 75 years
- •Individuals diagnosed with localized or limited-stage hormone receptor-positive breast cancer who require the use of aromatase inhibitors
- •Patients who have experienced new onset or worsening of joint pain after aromatase inhibitor treatment
- •Individuals whose joint pain symptoms have persisted for at least 2 months
- •Patients who reported joint pain of 3 or higher on the BPI-K (Korean version of the Brief Pain Inventory) during the past week at the time of screening.
- •Patients who can read the symptom questionnaire, understand its meaning, and answer the questions.
- •Patients who have voluntarily consented to the clinical plan and follow-up in writing, as approved by the Institutional Investigation Board (IRB).
排除标准
- •Patients with Stage IV (metastatic) breast cancer.
- •Within one month of the completion of surgery, chemotherapy, or radiation therapy (provided that chemotherapy is limited to cytotoxic chemotherapy).
- •Those who have received intramuscular corticosteroids or intra-articular steroid injections within 4 weeks (28 days) of the screening time in relation to joint pain symptoms.
- •Those who have received oral corticosteroids, opioid analgesics, topical analgesics, acupuncture, alternative medicine treatments, or physical therapy within 1 week (7 days) of the screening time in relation to joint pain symptoms.
- •Those who plan to initiate new drug treatments (e.g., steroids) or invasive procedures (e.g., intra-articular injections) that may affect AIA during the study period.
- •Individuals with active inflammatory joint diseases (rheumatoid arthritis, lupus, ankylosing spondylitis, etc.), metabolic joint diseases (gout, etc.), fibromyalgia, or other clear causes of joint pain (however, a history of osteoarthritis is not excluded).
- •Cases where acupuncture or pharmacopuncture is contraindicated (severe hemorrhagic disease, severe aversion or fear of invasive treatment).
- •Patients with a history of fracture within the last 6 months or who have undergone surgery on joints such as the knee or hand.
- •Cases of uncontrolled severe mental illness or cognitive impairment.
- •Cases with other diseases or factors deemed inappropriate for the clinical trial.
- •Individuals participating in another clinical study within 4 weeks (28 days) prior to the clinical study screening.
研究组 & 干预措施
Pharmacopuncture group
Participants in this group will receive pharmacopuncture treatment alongside standard treatment twice a week for a total of six weeks.
Under the autonomous judgment of the clinician, appropriate pharmacopuncture fluid and dosage shall be selected and administered to areas deemed effective for improving the study subjects' symptoms; the acupoints, types of pharmacopuncture fluid, and dosages shall be separately noted. The procedure shall be performed by a licensed Korean medicine practitioner who has held the license for at least 5 years.
For example:
- Upper Extremity Pain
- Shoulder: LI15, SJ14, SI9, SI10
- Scapula: SI11, SI12, SI14, UB43
- Elbow: LI11, LU5, SJ10), SJ5, LI4
- Hand/Fingers: SI3, LI3, EX-UE9s
- Lower Extremity Pain
- Hip: GB30, UB37, GB29
- Knee: ST34, ST35, GB34, GB35, Sp9
- Leg: UB57, UB58
- Ankle: St41, SP5, GB40, UB60, KI3
- Foot/Toe: SP4, UB65, EX-UE10s
干预措施: pharmacopuncture therapy (Procedure)
Control group
Administration of drugs according to the clinician's judgement from the drug classifications below
- NSAIDs
- Analgesics not subject to study exclusion criteria
- Acetaminophen, Ibuprofen, COX 2 inhibitors, Tramadol, etc. 3. Neuropathic drugs - ATC code M01, M02, M03, N02, N03; gabapentin, pregabalin, N06; duloxetine, etc.
干预措施: Conventional therapy (Procedure)
结局指标
主要结局
Change in Brief pain inventory-Korean version (BPI-K)
时间窗: visit 13 (week 6)
Change in BPI-K measured at the Visit 13 relative to baseline. Scores range from 0 to 10, with higher scores indicating greater pain severity or pain-related interference and therefore worse outcomes.
次要结局
- Change in Brief pain inventory-Korean version (BPI-K) at weeks 10(visit 14 (week 10))
- shoulder disability questionnaire (SDQ)(visit 7 (week 3), visit 13 (week 6), visit 14 (week 10))
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(visit 7 (week 3), visit 13 (week 6), visit 14 (week 10))
- European Organization for Research and Treatment of Cancer - quality of life questionnaire - core 30 (EORTC-QLQ-C30)(visit 7 (week 3), visit 13 (week 6), visit 14 (week 10))
研究者
Jee Young Lee
Assistant Professor
Ilsan Cha hospital