Airwave Compression Therapy to Prevent Breast Cancer-related Lymphedema

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

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).

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: standard care: health education and routine functional exercise; Device: airwave compression therapy

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 Type: Interventional
• Enrollment (Estimated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhi-Yong Wu, Dr.; Phone Number: 008613502953050; Email: stwzy@163.com

Study Locations

• China
  • Guangdong
    • Shantou, Guangdong, China, 510000
      • Recruiting
      • Shantou Central Hospital
      • Contact: Wan-Lin Zhan, Dr.; Phone Number: 008619830233390; Email: 287822522@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; standard care: health education and routine functional exercise	Other: standard care: health education and routine functional exercise; standard care: health education and routine functional exercise
Experimental: experimental group; standard care: health education and routine functional exercise;; airwave compression therapy	Other: standard care: health education and routine functional exercise; standard care: health education and routine functional exercise; Device: airwave compression therapy; Airwave compression therapy was given to patients after breast cancer surgery to treat the ipsilateral upper limb; Other Names: Airwave pressure therapy，intermittent pneumatic compression pump，IPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of lymphedema	Incidence of lymphedema of ipsilateral upper limb	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms	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.	18 months
Quality of life assessment	FACT-B (V4.0)	18 months

Collaborators and Investigators

• Sponsor: Shantou Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 9, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 9, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; breast cancer-related lymphedema; airwave compression therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Breast Diseases; Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: ShantouCH003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No