Pharmacopuncture for Aromatase Inhibitor Induced Arthralgia (AIA)

NCT07789717 | Recruiting DMC

• 1 other identifier: ICICC-CT-25-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Breast Cancer; Aromatase Inhibitor; Aromatase Inhibitor Induced Arthralgia

Keywords

aromatase inhibitor induced arthralgia; pharmacopuncture

Outcome Measures

Primary Outcomes (1)

• Change 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.

  visit 13 (week 6)

Secondary Outcomes (4)

• 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)

Study Arms (2)

Pharmacopuncture group

EXPERIMENTAL

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 1. Shoulder: LI15, SJ14, SI9, SI10 2. Scapula: SI11, SI12, SI14, UB43 3. Elbow: LI11, LU5, SJ10), SJ5, LI4 4. Hand/Fingers: SI3, LI3, EX-UE9s * Lower Extremity Pain 1. Hip: GB30, UB37, GB29 2. Knee: ST34, ST35, GB34, GB35, Sp9 3. Leg: UB57, UB58 4. Ankle: St41, SP5, GB40, UB60, KI3 5. Foot/Toe: SP4, UB65, EX-UE10s

Procedure: pharmacopuncture therapy

Control group

ACTIVE COMPARATOR

Administration of drugs according to the clinician's judgement from the drug classifications below 1. NSAIDs 2. 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.

Procedure: Conventional therapy

Interventions

pharmacopuncture therapy PROCEDURE

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.

Pharmacopuncture group

Conventional therapy PROCEDURE

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.

Control group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ilsan Cha hospital: lead

Study Sites (3)

Daejeon University Daejeon Korean Medicine Hospital

Daejeon, Daejeon, 35235, South Korea

RECRUITING

Cha Ilsan Medical Center

Goyang-si, Gyeonggi-do, 10414, South Korea

RECRUITING

Catholic Kwandong University International St. Mary's Hospital

Incheon, Incheon, 22711, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jee Young Lee

CONTACT

+82148717520; happiade@chamc.co.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 27, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

KR (3)