Electroacupuncture vs. Auricular Acupressure vs. Waitlist Control for Breast Cancer Endocrine Therapy-Related Joint Pain
Recruiting · NCT07490938 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
6 locations listed.
- Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital - Tianjin, China
- Tianjin Medical University Cancer Institute & Hospital - Tianjin, China
- Affiliated Hospital of Qinghai University - Xining, China
- Qinghai Provincial Hospital of Traditional Chinese Medicine - Xining, China
- Hubei Cancer Hospital - Wuhan, Hubei, China
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine - Tianjin, Tianjin Municipality, China