Breast Cancer SurvivorsEASENCT07490938
Electroacupuncture vs. Auricular Acupressure vs. Waitlist Control for Breast Cancer Endocrine Therapy-Related Joint Pain
A study testing Electroacupuncture Group and Auricular Acupressure Group in people with Breast Cancer Survivors and Endocrine Therapy-Induced Joint Pain, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine at 6 sites in China.
Trial summary
The purpose of this pragmatic, multicenter, randomized controlled trial is to evaluate the clinical effectiveness and safety of electroacupuncture and auricular acupressure for improving joint pain related to endocrine therapy in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer Survivors, Endocrine Therapy-Induced Joint Pain
- What is being tested?
- Electroacupuncture Group and Auricular Acupressure Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 6 sitesChina
- Study dates
- 1 Apr 2026to 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed breast cancer, stage I-IV, according to the AJCC Cancer Staging Manual (8th edition);
- Aged 18-75 years;
- Experiencing joint pain attributed to endocrine therapy, including localized or generalized joint pain, with symptoms persisting for at least 1 week;
- Completion of all planned surgeries, chemotherapy, and radiotherapy, with a scheduled continuation of endocrine therapy for at least 1 additional year;
- Self-reported worst joint pain score of ≥3 on a 0-10 Visual Analogue Scale (VAS) during the past week;
- Life expectancy ≥1 year;
- Voluntarily sign the informed consent.
Who cannot join
- Bone metastases involving the same site as the affected joint attributed to endocrine therapy;
- History of fracture or surgery involving the affected joints within the past 6 months;
- Implanted electronic medical devices;
- Not suitable for acupuncture, including but not limited to bleeding tendencies (e.g. coagulation disorders or purpura) or local skin lesions at the intended acupoint sites.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jing Xue contact
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300120
Li Li, PhD, 18222626653, lilitcm@foxmail.com
- Recruiting
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin
Hailong Wang, 86+13021368172, 13021368172@163.com
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin
bin Wang, 86+13820156627, wbin8888@163.com
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
xuan xuan Wang, PhD, 18986024169, caidi87@163.com
- Recruiting
Affiliated Hospital of Qinghai University
Xining
Miaozhou Wang, 86+18609780037, wangmiaozhou@163.com
- Recruiting
Qinghai Provincial Hospital of Traditional Chinese Medicine
Xining
Xiumei Feng, 86+19282247274, 332908772@qq.com
About this study
Official title: Electroacupuncture Versus Auricular Acupressure Versus WaitliSt Control for Endocrine Therapy-related Joint Pain in Patients With Breast Cancer (EASE): A Pragmatic Multicenter Randomised Controlled Trial
The purpose of this pragmatic, multicenter, randomized controlled trial is to evaluate the clinical effectiveness and safety of electroacupuncture and auricular acupressure for improving joint pain related to endocrine therapy in breast cancer patients. A total of 200 participants will be recruited and randomly assigned to one of three groups: the Electroacupuncture Group (n=80), the Auricular Acupressure Group (n=80), or the Waitlist Control Group (n=40), using a central stratified block randomization method.
The primary objective is to compare changes in Worst Pain Item score among the three groups from baseline to the end of the treatment period, as measured by the Brief Pain Inventory-Short Form (BPI-SF). Secondary objectives include assessing pain interference, overall health status through the PROMIS scale, and quality of life specifically related to endocrine therapy using the FACT-ES. Additionally, the study will evaluate analgesic medication use (QAQ), patient expectations (Acupuncture Expectancy Scale), treatment adherence, and the occurrence of adverse events. By comparing these interventions, this study aims to generate high-quality evidence for the management of treatment-related arthralgia in breast cancer survivors.
- Being tested
- Electroacupuncture Group, Auricular Acupressure Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroacupuncture GroupProcedure or surgery
Electroacupuncture is performed using the basic prescription combined with the prescription for the affected joints. Basic prescription: Shuigou (GV26), Hegu (LI4), Neiguan (PC6), Zusanli (ST36), Yanglingquan (GB34), Taichong (LR3), Sanyinjiao (SP6). On this basis, 1 to 4 additional acupoints are selected based on the two most severely affected joint areas.
Needle selection: The acupuncture needles (40 or 75 mm x 0.25 mm gauge, and 40 mm x 0.18 mm gauge, Huatuo, Suzhou, China) will be used.
An electroacupuncture stimulator (SDZ-V, Huatuo, Suzhou, China) will be used, delivering alternating frequencies of 2 Hz/10 Hz with no more than four electrode pairs simultaneously.
Auricular Acupressure GroupProcedure or surgery
The auricular acupressure protocol is formed by combining the basic auricular point prescription and the auricular point prescription corresponding to the affected joints. The basic points include Shenmen, Sympathetic, Endocrine, and Subcortex, while the additional points are selected by the acupuncturist based on the 1-2 joint regions with the most pain as reported by the patient. Once identified, Vaccaria seed (Zhongyan Taihe, Beijing, China) is taped onto the points until the patient perceives a distinct sensation of soreness or tenderness. Participants will be instructed to apply pressure to each ear three times per day, pressing each side for approximately 3 minutes per session. The auricular patches will be removed 2 to 4 days after during a follow-up visit at the clinic.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture Group | Experimental | The electroacupuncture protocol follows a standardized framework consisting of a core acupoint formula combined with individualized local points. The core formula includes GV26 (Shuigou), LI4 (Hegu), PC6 (Neiguan), ST36 (Zusanli), GB34 (Yanglingquan), LR3 (Taichong), and SP6 (Sanyinjiao). For the individualized component, 1 to 4 additional acupoints are selected based on the two most severely affected joint areas.
Acupuncture frequency: Acupuncture is performed twice a week, 30 minutes each time, for 8 weeks, totaling 16 sessions. Receives: Procedure: Electroacupuncture Group |
| Auricular Acupressure Group | Experimental | Auricular point sticking prescription: Basic auricular points combined with the corresponding auricular points of the affected joints.
Auricular point frequency: Twice a week, the sticker is removed after 2 days and reapplied the next day, for 8 weeks, totaling 16 sessions. Receives: Procedure: Auricular Acupressure Group |
| Waitlist Control Group | No intervention | After random grouping, only the basic treatment plan is adopted, and no acupoint stimulation therapy is received within 16 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Worst Pain score of the Brief Pain Inventory-Short Form
A single-item numeric rating scale. Min: 0, Max: 10. Higher scores mean a worse outcome (more severe pain).
Measured: Baseline, 4 weeks, 8 weeks, 12weeks, 16 weeks
Secondary outcomes (6)
The pain severity score of the Brief Pain Inventory-Short Form
The mean of 4 items (worst, least, average, and pain "now"). Min: 0, Max: 10. Higher scores mean a worse outcome.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
The pain interference score of the Brief Pain Inventory-Short Form
The mean of 7 items (general activity, mood, walking, work, relations, sleep, enjoyment). Min: 0, Max: 10. Higher scores mean a worse outcome.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
The Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) scale
A scale assessing quality of life in patients receiving endocrine therapy. Min: 0, Max: 76 (for the ES subscale). Higher scores mean a worse outcome.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
The Patient-Reported Outcomes Measurement Information System Global Health scale (PROMIS Global Health)
10 items assessing physical, mental, and social health. Results are typically converted to T-scores. Min: 0, Max: 100(standardized). Higher scores mean a better outcome (better health).
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
The EuroQol 5-Dimension 5-Level (EQ-5D-5L)
It comprises two primary components: the EQ-5D-5L Index Score and the EQ Visual Analogue Scale (EQ VAS). For the Index Score, values typically range from less than 0 to 1, where higher scores indicate better health-related quality of life. The EQ VAS provides a self-rated assessment of overall health on a scale from 0 to 100, where higher scores represent better self-rated health.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Credibility/Expectancy Questionnaire（CEQ）
It utilizes two different scoring formats-a 1-9 Likert scale and a 0%-100% percentage scale. The composite score for a single factor typically ranges from a minimum of 3 to a maximum of 27. Higher scores indicate a better outcome, representing a higher psychological expectation for symptom improvement.
Measured: Baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Apr 2026
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorsStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Li, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- Investigators
- Li Li, Study chair, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490938
- Sponsor's protocol ID
- LCLX2026001
- Other IDs
- GZY-KJS-2025-061
- Acronym
- EASE
- Status last verified
- Aug 2026
- First submitted
- 12 Mar 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to protect participant privacy and comply with institutional data governance policies.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroacupuncture Versus Auricular Acupressure Versus WaitliSt Control for Endocrine Therapy-related Joint Pain in Patients With Breast Cancer (EASE): A Pragmatic Multicenter Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07490938
- Acronym / sponsor ID
- EASE / LCLX2026001
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Teaching Hospital of Tianjin University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Mar 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.
The purpose of this pragmatic, multicenter, randomized controlled trial is to evaluate the clinical effectiveness and safety of electroacupuncture and auricular acupressure for improving joint pain related to endocrine therapy in breast cancer patients. A total of 200 participants will be recruited and randomly assigned to one of three groups: the Electroacupuncture Group (n=80), the Auricular Acupressure Group (n=80), or the Waitlist Control Group (n=40), using a central stratified block randomization method.
The primary objective is to compare changes in Worst Pain Item score among the three groups from baseline to the end of the treatment period, as measured by the Brief Pain Inventory-Short Form (BPI-SF). Secondary objectives include assessing pain interference, overall health status through the PROMIS scale, and quality of life specifically related to endocrine therapy using the FACT-ES. Additionally, the study will evaluate analgesic medication use (QAQ), patient expectations (Acupuncture Expectancy Scale), treatment adherence, and the occurrence of adverse events. By comparing these interventions, this study aims to generate high-quality evidence for the management of treatment-related arthralgia in breast cancer survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture Group | Experimental | Procedure: Electroacupuncture GroupThe electroacupuncture protocol follows a standardized framework consisting of a core acupoint formula combined with individualized local points. The core formula includes GV26 (Shuigou), LI4 (Hegu), PC6 (Neiguan), ST36 (Zusanli), GB34 (Yanglingquan), LR3 (Taichong), and SP6 (Sanyinjiao). For the individualized component, 1 to 4 additional acupoints are selected based on the two most severely affected joint areas. Acupuncture frequency: Acupuncture is performed twice a week, 30 minutes each time, for 8 weeks, totaling 16 sessions. |
| Auricular Acupressure Group | Experimental | Procedure: Auricular Acupressure GroupAuricular point sticking prescription: Basic auricular points combined with the corresponding auricular points of the affected joints. Auricular point frequency: Twice a week, the sticker is removed after 2 days and reapplied the next day, for 8 weeks, totaling 16 sessions. |
| Waitlist Control Group | No intervention | –After random grouping, only the basic treatment plan is adopted, and no acupoint stimulation therapy is received within 16 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed breast cancer, stage I-IV, according to the AJCC Cancer Staging Manual (8th edition);
- Aged 18-75 years;
- Experiencing joint pain attributed to endocrine therapy, including localized or generalized joint pain, with symptoms persisting for at least 1 week;
- Completion of all planned surgeries, chemotherapy, and radiotherapy, with a scheduled continuation of endocrine therapy for at least 1 additional year;
- Self-reported worst joint pain score of ≥3 on a 0-10 Visual Analogue Scale (VAS) during the past week;
Key exclusion criteria (4 listed)
- Bone metastases involving the same site as the affected joint attributed to endocrine therapy;
- History of fracture or surgery involving the affected joints within the past 6 months;
- Implanted electronic medical devices;
- Not suitable for acupuncture, including but not limited to bleeding tendencies (e.g. coagulation disorders or purpura) or local skin lesions at the intended acupoint sites.
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 |
|---|---|---|
| Electroacupuncture GroupElectroacupuncture is performed using the basic prescription combined with the prescription for the affected joints. Basic prescription: Shuigou (GV26), Hegu (LI4), Neiguan (PC6), Zusanli (ST36), Yanglingquan (GB34), Taichong (LR3), Sanyinjiao (SP6). On this basis, 1 to 4 additional acupoints are selected based on the two most severely affected joint areas. Needle selection: The acupuncture needles (40 or 75 mm x 0.25 mm gauge, and 40 mm x 0.18 mm gauge, Huatuo, Suzhou, China) will be used. An electroacupuncture stimulator (SDZ-V, Huatuo, Suzhou, China) will be used, delivering alternating frequencies of 2 Hz/10 Hz with no more than four electrode pairs simultaneously. | Procedure or surgery | Electroacupuncture Group |
| Auricular Acupressure GroupThe auricular acupressure protocol is formed by combining the basic auricular point prescription and the auricular point prescription corresponding to the affected joints. The basic points include Shenmen, Sympathetic, Endocrine, and Subcortex, while the additional points are selected by the acupuncturist based on the 1-2 joint regions with the most pain as reported by the patient. Once identified, Vaccaria seed (Zhongyan Taihe, Beijing, China) is taped onto the points until the patient perceives a distinct sensation of soreness or tenderness. Participants will be instructed to apply pressure to each ear three times per day, pressing each side for approximately 3 minutes per session. The auricular patches will be removed 2 to 4 days after during a follow-up visit at the clinic. | Procedure or surgery | Auricular Acupressure Group |
Primary outcome
The Worst Pain score of the Brief Pain Inventory-Short Form
Time frame: Baseline, 4 weeks, 8 weeks, 12weeks, 16 weeks
A single-item numeric rating scale. Min: 0, Max: 10. Higher scores mean a worse outcome (more severe pain).
6 secondary outcomes
The pain severity score of the Brief Pain Inventory-Short Form
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
The pain interference score of the Brief Pain Inventory-Short Form
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
The Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) scale
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
The Patient-Reported Outcomes Measurement Information System Global Health scale (PROMIS Global Health)
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
The EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Credibility/Expectancy Questionnaire（CEQ）
Time frame: Baseline, 4 weeks, 8 weeks
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 2 Sep 2026.
- Individual participant dataSharing planned: No. IPD will not be shared to protect participant privacy and comply with institutional data governance policies.
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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.
Jing Xue contact
Li Li study chair
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture Group and Auricular Acupressure Group in people with Breast Cancer Survivors and Endocrine Therapy-Induced Joint Pain, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine at 6 sites in China.
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 4 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 2 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 6 sites in China. 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 Li Li (86+18222626653, lilitcm@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Worst Pain score of the Brief Pain Inventory-Short Form (time frame: Baseline, 4 weeks, 8 weeks, 12weeks, 16 weeks). 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 2 Sep 2026.