Pharmacopuncture for AI-Induced Arthralgia in Breast Cancer Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pragmatic pilot trial compares pharmacopuncture plus conventional therapy to conventional therapy alone in women with hormone receptor-positive breast cancer experiencing AI-induced arthralgia. Eligible participants are 19–75 years old with persistent joint pain after AI treatment and a baseline pain score of 3 or higher. The study evaluates efficacy, safety, and cost-effectiveness of the pharmacopuncture approach in addition to standard analgesics. Treatments occur in real-world clinical settings across multiple Korean medical centers. Outcomes will inform whether pharmacopuncture can be a beneficial adjunct for managing AI-related arthralgia.

Why it matters

Who can join: the full rules

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.

Where it's running

• Daejeon University Daejeon Korean Medicine Hospital
  Daejeon, Daejeon, South Korea Recruiting
• Cha Ilsan Medical Center
  Goyang-si, Gyeonggi-do, South Korea Recruiting
• Catholic Kwandong University International St. Mary's Hospital
  Incheon, Incheon, South Korea Recruiting

Study contacts

• Study coordinator: Jee Young Lee
• Email: happiade@chamc.co.kr
• Phone: +82148717520

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.