Airwave Compression Therapy to Prevent Breast Cancer-related Lymphedema
July 9, 2024 updated by: Si-Qi Qiu, Shantou Central Hospital
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhi-Yong Wu, Dr.
- Phone Number: 008613502953050
- Email: stwzy@163.com
Study Locations
-
-
Guangdong
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Shantou, Guangdong, China, 510000
- Recruiting
- Shantou Central Hospital
-
Contact:
- Wan-Lin Zhan, Dr.
- Phone Number: 008619830233390
- Email: 287822522@qq.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group
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 was given to patients after breast cancer surgery to treat the ipsilateral upper limb
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of lymphedema
Time Frame: 18 months
|
Incidence of lymphedema of ipsilateral upper limb
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptoms
Time Frame: 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.
|
18 months
|
|
Quality of life assessment
Time Frame: 18 months
|
FACT-B (V4.0)
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
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