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Trial Title:
Airwave Compression Therapy to Prevent Breast Cancer-related Lymphedema
NCT ID:
NCT06495034
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Lymphedema
Breast Cancer Lymphedema
Conditions: Keywords:
breast cancer-related lymphedema
airwave compression therapy
quality of life
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
airwave compression therapy
Description:
Airwave compression therapy was given to patients after breast cancer surgery to treat
the ipsilateral upper limb
Arm group label:
experimental group
Other name:
Airwave pressure therapy，intermittent pneumatic compression pump，IPC
Intervention type:
Other
Intervention name:
standard care: health education and routine functional exercise
Description:
standard care: health education and routine functional exercise
Arm group label:
control group
Arm group label:
experimental group
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shantou Central Hospital
Address:
City:
Shantou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Wan-Lin Zhan, Dr.
Phone:
008619830233390
Email:
287822522@qq.com
Start date:
July 1, 2023
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Shantou Central Hospital
Agency class:
Other
Source:
Shantou Central Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06495034
