Airwave Compression Therapy to Prevent Breast Cancer-related Lymphedema

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Device: airwave compression therapy

• Registration Number: NCT06495034
• Lead Sponsor: Shantou Central Hospital

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.

Study Timeline

• Study Start: 2023-07-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-09
• Last Update Submitted: 2024-07-09
• Study First Posted: 2024-07-10
• Last Update Posted: 2024-07-10
• Primary Completion: 2025-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	airwave compression therapy	1. standard care: health education and routine functional exercise; 2. airwave compression therapy

Primary Outcome Measures

Name	Time	Method
Incidence of lymphedema	18 months	Incidence of lymphedema of ipsilateral upper limb

Secondary Outcome Measures

Name	Time	Method
Quality of life assessment	18 months	FACT-B (V4.0)
Symptoms	18 months	Questionnaire. The level of subjective symptoms( pain, heaviness, paresthesia) at each time point was recorded with a 0-3 four-point scale questionnaire. 0-3 indicated no symptoms, mild, moderate, and severe, respectively.

Trial Locations

Locations (1)

Shantou Central Hospital; 🇨🇳 Shantou, Guangdong, China