A Randomized Controlled Study on Early Intervention of Airwave Compression Therapy to Prevent Breast Cancer-related Upper Limb Lymphedema

Shantou Central Hospital1 site in 1 country132 target enrollmentJuly 1, 2023

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Shantou Central Hospital
Enrollment: 132
Locations: 1
Primary Endpoint: Incidence of lymphedema
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to explore the effectiveness of early intervention of airwave compression therapy to prevent the occurrence of postoperative breast cancer-related lymphedema(BCRL).

Detailed Description

This study aims to explore the effectiveness of early intervention of airwave compression therapy to prevent the occurrence of postoperative breast cancer-related lymphedema (BCRL), hereby improving the quality of life of patients with breast cancer. Furthermore, we will perform exploratory analyses to investigate the predictive values of patient plasma cytokines to the occurrence and development of BCRL.

Registry

clinicaltrials.gov

Start Date

July 1, 2023

End Date

June 30, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Shantou Central Hospital

Responsible Party

Principal Investigator

Si-Qi Qiu

Principal Investigator

Shantou Central Hospital

Eligibility Criteria

Inclusion Criteria

•Volunteer to participate in this clinical trial. Fully understand and be informed about the study and sign an informed consent form (ICF). Willing to follow and able to complete all test procedures;
•Female, ≥18 years old and ≤70 years old at the time of signing the ICF;
•Patients with unilateral breast cancer diagnosed by histopathology or cytology;
•No distant metastasis;
•To undergo unilateral axillary sentinel lymph node biopsy or unilateral axillary lymph node dissection;
•Have not received any treatment for arm lymphedema;
•No lymphangitis and other infections.

Exclusion Criteria

•Breast malignancy derived from other tumors rather than the primary breast cancer;
•Patients with second primary tumor;
•Contraindication to airwave compression therapy: Acute venous thrombosis; Acute inflammatory skin disease; Erysipelas; Arrhythmia; Pulmonary edema; Unstable hypertension; People with artificial pacemakers; Deep thrombophlebitis;
•Have a history of mental illness or other reasons can not cooperate with treatment;
•Embolism, cardiogenic edema, hepatogenic edema and the history of upper limb trauma and other related complications;
•Patients using any medication that affects fluid or electrolyte balance.