Airwave Compression Therapy to Prevent Breast Cancer-related Lymphedema

NCT06495034 | Recruiting

• 1 other identifier: ShantouCH003
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Keywords

breast cancer-related lymphedema; airwave compression therapy; quality of life

Outcome Measures

Primary Outcomes (1)

• Incidence of lymphedema

  Incidence of lymphedema of ipsilateral upper limb

  18 months

Secondary Outcomes (2)

• Symptoms

  18 months

• Quality of life assessment

  18 months

Study Arms (2)

control group

ACTIVE COMPARATOR

standard care: health education and routine functional exercise

Other: standard care: health education and routine functional exercise

experimental group

EXPERIMENTAL

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

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

Interventions

airwave compression therapy DEVICE

Airwave compression therapy was given to patients after breast cancer surgery to treat the ipsilateral upper limb

Also known as: Airwave pressure therapy，intermittent pneumatic compression pump，IPC

experimental group

standard care: health education and routine functional exercise OTHER

standard care: health education and routine functional exercise

control group; experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shantou Central Hospital: lead

Study Sites (1)

Shantou Central Hospital

Shantou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zhi-Yong Wu, Dr.

CONTACT

008613502953050; stwzy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 10, 2024
• Study Start: July 1, 2023
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)