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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06495034

Enrollment

132

Registered

2024-07-10

Start date

2023-07-01

Completion date

2026-06-30

Last updated

2024-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

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

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.

Interventions

DEVICEairwave compression therapy

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

OTHERstandard care: health education and routine functional exercise

standard care: health education and routine functional exercise

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of lymphedema	18 months	Incidence of lymphedema of ipsilateral upper limb

Secondary

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

Countries

China

Contacts

Primary ContactZhi-Yong Wu, Dr.

stwzy@163.com008613502953050

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026