Pharmacopuncture for Aromatase Inhibitor Induced Arthralgia (AIA)

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

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.

Inclusion Criteria:

1. Women aged 19 to 75 years
2. Individuals diagnosed with localized or limited-stage hormone receptor-positive breast cancer who require the use of aromatase inhibitors
3. Patients who have experienced new onset or worsening of joint pain after aromatase inhibitor treatment
4. Individuals whose joint pain symptoms have persisted for at least 2 months
5. 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.
6. Patients who can read the symptom questionnaire, understand its meaning, and answer the questions.
7. Patients who have voluntarily consented to the clinical plan and follow-up in writing, as approved by the Institutional Investigation Board (IRB).

Exclusion Criteria:

1. Patients with Stage IV (metastatic) breast cancer.
2. Within one month of the completion of surgery, chemotherapy, or radiation therapy (provided that chemotherapy is limited to cytotoxic chemotherapy).
3. 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.
4. 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.
5. 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.
6. 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).
7. Cases where acupuncture or pharmacopuncture is contraindicated (severe hemorrhagic disease, severe aversion or fear of invasive treatment).
8. Patients with a history of fracture within the last 6 months or who have undergone surgery on joints such as the knee or hand.
9. Cases of uncontrolled severe mental illness or cognitive impairment.
10. Cases with other diseases or factors deemed inappropriate for the clinical trial.
11. Individuals participating in another clinical study within 4 weeks (28 days) prior to the clinical study screening.