Clinical trial · Interventional
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
NCT07789717CI-TRIAL-00124165P-ATx for AIArecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aromatase Inhibitor | — | UNRESOLVED | — |
| Aromatase Inhibitor Induced Arthralgia | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional therapy | Procedure | — | UNRESOLVED |
| pharmacopuncture therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pharmacopuncture group
- description
- 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
- interventionNames
- Procedure: pharmacopuncture therapy
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.