Airwave Compression Therapy to Prevent Breast Cancer-related Lymphedema

NCT ID: NCT06495034

Last Updated: 2024-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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control group

standard care: health education and routine functional exercise

Group Type ACTIVE_COMPARATOR

standard care: health education and routine functional exercise

Intervention Type OTHER

standard care: health education and routine functional exercise

experimental group

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

Group Type EXPERIMENTAL

airwave compression therapy

Intervention Type DEVICE

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

standard care: health education and routine functional exercise

Intervention Type OTHER

standard care: health education and routine functional exercise

Interventions

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airwave compression therapy

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

Intervention Type DEVICE

standard care: health education and routine functional exercise

standard care: health education and routine functional exercise

Intervention Type OTHER

Other Intervention Names

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Airwave pressure therapy,intermittent pneumatic compression pump,IPC

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shantou Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Si-Qi Qiu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shantou Central Hospital

Shantou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhi-Yong Wu, Dr.

Role: CONTACT

008613502953050

Facility Contacts

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Wan-Lin Zhan, Dr.

Role: primary

008619830233390

Other Identifiers

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ShantouCH003

Identifier Type: -

Identifier Source: org_study_id

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