Protocol for randomized controlled trial of TEAS pretreatment for breast cancer-related lymphedema

IntroductionBreast cancer-related lymphedema (BCRL) is a serious and intractable complication that severely affects the quality of life and survival rates of cancer patients. Transcutaneous electrical acupoint stimulation (TEAS) has been applied in China for the treatment of lymphedema. However, there is currently no high-quality evidence-based data confirming the efficacy, safety, and preventive therapeutic role of TEAS for BCRL. This study aims to evaluate the efficacy and safety of TEAS pretreatment for BCRL through a multicenter, prospective, randomized, sham-controlled, parallel-group clinical trial, thereby providing evidence-based medical evidence.Methods and analysisA total of 72 breast cancer participants scheduled for axillary lymph node dissection will be recruited from Yunnan Provincial Hospital of Traditional Chinese Medicine and the First Affiliated Hospital of Kunming Medical University. They will randomly assigned in a 1:1 ratio to the TEAS group or the Sham TEAS group, with 36 cases in each group. Treatment will be administered once daily from the first day before surgery to the third day after surgery (paused on the surgery day), and subsequently twice a week for 4 consecutive weeks, totaling 12 intervention sessions. This will be followed by an 18-month follow-up period. The primary outcome measures are the incidence and time of onset of lymphedema within 18-month postoperatively. Secondary outcome measures include: VAS scores for perceived swelling and lymphedema-related symptoms evaluated at baseline (T0), from preoperative to postoperative day 3 (T1-T4), upon completion of twice-weekly post-discharge treatments (T5-T12), and during monthly follow-ups until 18 months postoperatively (T13-T29); changes in circumference, edema stage, and severity of the affected limb evaluated at T0, before and after treatments from preoperative to postoperative day 3 (T1a/b-T4a/b), before and after twice-weekly post-discharge treatments (T5a/b-T12a/b), and at T29; skin thickness ultrasound and lymphangiography of the affected limb performed at T0, T2, T12, and T29; and serum inflammatory factor levels measured at T0, T4, and T12. Adverse events occurring during the trial will be recorded.DiscussionThis study aims to evaluate the efficacy and safety of TEAS pretreatment for BCRL. If effective, TEAS will become a non-invasive adjunct therapy for preventing BCRL.Clinical trial registrationChinese Clinical Trial Registry [website], identifier ChiCTR2400088117.