Airwave Compression Therapy to Prevent Breast Cancer-related Lymphedema

Shantou Central Hospital

Status: Enrolling

Conditions: Breast Cancer

Treatments: Device: airwave compression therapy; Other: standard care: health education and routine functional exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06495034

ShantouCH003

Details and patient eligibility

About

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).

Full 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.

Enrollment: 132 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

control group

Active Comparator group

Description:

standard care: health education and routine functional exercise

Treatment:

Other: standard care: health education and routine functional exercise

experimental group

Experimental group

Description:

1. standard care: health education and routine functional exercise; 2. airwave compression therapy

Treatment:

Other: standard care: health education and routine functional exercise

Device: airwave compression therapy