Breast CancerP-ATx for AIANCT07789717
Pharmacopuncture for Aromatase Inhibitor Induced Arthralgia (AIA)
A study testing pharmacopuncture therapy and Conventional therapy in people with Breast Cancer and Aromatase Inhibitor, run by Ilsan Cha hospital at 3 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Aromatase Inhibitor, Aromatase Inhibitor Induced Arthralgia
- What is being tested?
- pharmacopuncture therapy and Conventional therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 5 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 3 recruiting
- Recruiting
Daejeon University Daejeon Korean Medicine Hospital
Daejeon, Daejeon, 35235
Hwa Seung Yoo, 082-10-8232-2752, altyhs@dju.ac.kr
- Recruiting
Cha Ilsan Medical Center
Goyang-si, Gyeonggi-do, 10414
Jee Young Lee, 082-10-4871-7520, happiade@chamc.co.kr
- Recruiting
Catholic Kwandong University International St. Mary's Hospital
Incheon, Incheon, 22711
Tae Yong Park, 082-10-3624-9539, parktae9822@daum.net
About this study
Official title: 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
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.
Read the 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.
- Being tested
- pharmacopuncture therapy, Conventional therapy
- Keywords
- aromatase inhibitor induced arthralgia, pharmacopuncture
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmacopuncture therapyProcedure or surgery
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.
Conventional therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: visit 13 (week 6)
Secondary outcomes (4)
Change in Brief pain inventory-Korean version (BPI-K) at weeks 10
Change in BPI-K measured at Visit 14 relative to baseline.
Measured: visit 14 (week 10)
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.
Measured: visit 7 (week 3), visit 13 (week 6), visit 14 (week 10)
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.
Measured: 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)
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.
Measured: visit 7 (week 3), visit 13 (week 6), visit 14 (week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start5 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ilsan Cha hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jee Young Lee, Ilsan Cha hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07789717
- Sponsor's protocol ID
- ICICC-CT-25-01
- Other IDs
- U1111-1346-6670
- Acronym
- P-ATx for AIA
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing status for this study is currently undecided. Details regarding the availability of individual participant data will be updated upon study completion, after permission of research project management team of Korea health industry development institute.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07789717
- Acronym / sponsor ID
- P-ATx for AIA / ICICC-CT-25-01
- Keywords
- aromatase inhibitor induced arthralgia, pharmacopuncture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ilsan Cha hospitalUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacopuncture group | Experimental | Procedure: pharmacopuncture therapyParticipants 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 |
| Control group | Active comparator | Procedure: Conventional therapyAdministration 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. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pharmacopuncture therapyIt 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. | Procedure or surgery | Pharmacopuncture group |
| Conventional therapyBased 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. | Procedure or surgery | Control group |
Primary outcome
Change in Brief pain inventory-Korean version (BPI-K)
Time frame: 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.
4 secondary outcomes
Change in Brief pain inventory-Korean version (BPI-K) at weeks 10
Time frame: visit 14 (week 10)
shoulder disability questionnaire (SDQ)
Time frame: visit 7 (week 3), visit 13 (week 6), visit 14 (week 10)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 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)
Time frame: visit 7 (week 3), visit 13 (week 6), visit 14 (week 10)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Undecided. Data sharing status for this study is currently undecided. Details regarding the availability of individual participant data will be updated upon study completion, after permission of research project management team of Korea health industry development institute.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmacopuncture therapy and Conventional therapy in people with Breast Cancer and Aromatase Inhibitor, run by Ilsan Cha hospital at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jee Young Lee (+82148717520, happiade@chamc.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brief pain inventory-Korean version (BPI-K) (time frame: visit 13 (week 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.