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Preventive effect of Transcutaneous Electrical Acupoint Stimulation(TAES) pre-treatment on lymphedema in patients undergoing axillary lymph node dissection for breast cancer: protocol for a randomized controlled trial

Preventive effect of Transcutaneous Electrical Acupoint Stimulation(TAES) pre-treatment on lymphedema in patients undergoing axillary lymph node dissection for breast cancer: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088117
Enrollment
Unknown
Registered
2024-08-12
Start date
2025-01-01
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer-related Lymphedema, BCRL

Interventions

Treatment group:Transcutaneous Electrical Acupoint Stimulation treatment
Control group:sham Transcutaneous Electrical Acupoint Stimulation treatment

Sponsors

Yunnan Provincial Hospital of TCM
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients who meet the above diagnostic criteria and whose clinical stage of breast cancer belongs to stage II or III; (2) Have undergone preoperative puncture, confirmed the diagnosis of invasive breast cancer and axillary lymph node metastasis, and are proposed to undergo axillary lymph node dissection; (3) No upper extremity lymphedema before surgery; (4) The age of onset is 18-75 years old; (5) Survival period of =3 years as clinically predicted by the surgeon; (6) Clear consciousness, no mental illness, no heart, liver, cerebrovascular, renal and other systemic diseases, independent daily life, able to cooperate with the completion of all interventions; (7) They should be completely voluntary and sign an informed consent form, and be willing to cooperate in receiving follow-up visits during the study period.

Exclusion criteria

Exclusion criteria: (1) Do not meet the above inclusion criteria; (2) Patients who are currently on medications or other treatment regimens that conflict with this case; (3) Patients with mental abnormalities, combined with severe cardiovascular, cerebrovascular, hepatic and renal disorders; (4) Those who have other diseases that are not suitable for the implementation of the program, such as skin diseases, coagulation disorders or infectious diseases. (5) Pregnant and lactating women; (6) Upper limb disability with cardiogenic, nephrogenic or malnutrition-induced edema. (7) Presence of venous thrombosis in the affected limb. (8) Patients who have a history of surgery or injury to the affected upper limb before breast cancer surgery;

Design outcomes

Primary

MeasureTime frame
visual analogue scale(VAS);Symptoms related to lymphedema;Comparison of Upper Limb Circumference Changes and Staging/Severity of Edema;

Secondary

MeasureTime frame
Lymphatic System Imaging;Security Assessment;Serum Tumor Necrosis Factor-a (TNF-a), High-Sensitivity C-Reactive Protein (hs-CRP), Procalcitonin (PCT);

Countries

China

Contacts

Public ContactZhao Rong

Yunnan Provincial Hospital of TCM/ Yunnan University of Chinese Medicine

kmzhaorong@qq.com+86 138 8865 9309

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026