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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
It is a modified form of acupuncture treatment in which a small amount of herbal medicine is inserted into acupoints. It is injected using sterile disposable tools.
Based on the clinician's judgement, prescriptions are made within the acceptable dosage range of drugs that are currently recommended in clinical practice. The prescription will be made by a hematology-oncology specialist with more than 10 years of experience.
Daejeon University Daejeon Korean Medicine Hospital
Daejeon, Daejeon, South Korea
RECRUITINGCha Ilsan Medical Center
Goyang-si, Gyeonggi-do, South Korea
RECRUITINGCatholic Kwandong University International St. Mary's Hospital
Incheon, Incheon, South Korea
RECRUITINGChange in Brief pain inventory-Korean version (BPI-K)
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.
Time frame: visit 13 (week 6)
Change in Brief pain inventory-Korean version (BPI-K) at weeks 10
Change in BPI-K measured at Visit 14 relative to baseline.
Time frame: visit 14 (week 10)
shoulder disability questionnaire (SDQ)
SDQ measured at week 3 (Visit 7), week 6 (Visit 13), and week 10 (Visit 14) relative to baseline. Scores range from 0 (no disability) to 100 (maximum disability), reflecting the percentage of painful or limited activities. Higher score means worse outcome.
Time frame: visit 7 (week 3), visit 13 (week 6), visit 14 (week 10)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
WOMAC measured at week 3 (Visit 7), week 6 (Visit 13), and week 10 (Visit 14) relative to baseline. It uses 24 items scored on a 0 to 4 Likert scale, where higher scores indicate worse symptoms.
Time frame: 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)
EORTC-QLQ-C30 measured at week 3 (Visit 7), week 6 (Visit 13), and week 10 (Visit 14) relative to baseline. Standardized scores range from 0 to 100 per each category.
Time frame: visit 7 (week 3), visit 13 (week 6), visit 14 (week 10)
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