Pharmacopuncture for Aromatase Inhibitor Induced Arthralgia (AIA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19-75
SponsorIlsan Cha hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
pharmacopuncture therapy
Procedure/SurgeryIt 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.
Conventional therapy
Procedure/SurgeryBased 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Pharmacopuncture groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
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.
Time frame
visit 13 (week 6)Secondary outcomes
1
Change in Brief pain inventory-Korean version (BPI-K) at weeks 10
Change in BPI-K measured at Visit 14 relative to baseline.
Time frame
visit 14 (week 10)2
shoulder disability questionnaire (SDQ)
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.
Time frame
visit 7 (week 3), visit 13 (week 6), visit 14 (week 10)3
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
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.
Time frame
visit 7 (week 3), visit 13 (week 6), visit 14 (week 10)4
European Organization for Research and Treatment of Cancer - quality of life questionnaire - core 30 (EORTC-QLQ-C30)
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.
Time frame
visit 7 (week 3), visit 13 (week 6), visit 14 (week 10)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov