Aromatase Inhibitor, Aromatase Inhibitor Induced Arthralgia, Breast Cancer
Conditions
Keywords
aromatase inhibitor induced arthralgia, pharmacopuncture
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.
Detailed description
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.
Interventions
PROCEDUREpharmacopuncture therapy
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.
PROCEDUREConventional therapy
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.
Sponsors
Ilsan Cha hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brief pain inventory-Korean version (BPI-K) | visit 13 (week 6) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brief pain inventory-Korean version (BPI-K) at weeks 10 | visit 14 (week 10) | Change in BPI-K measured at Visit 14 relative to baseline. |
| shoulder disability questionnaire (SDQ) | visit 7 (week 3), visit 13 (week 6), visit 14 (week 10) | 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. |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | visit 7 (week 3), visit 13 (week 6), visit 14 (week 10) | 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. |
| 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) | 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. |
Countries
South Korea
Contacts
CONTACTJee Young Lee
Outcome results
None listed