Effect of Prophylactic Medical Compression Therapy on the Reduction of Breast Cancer-related Lymphedema in Patients With Adjuvant Docetaxel Chemotherapy: a Randomized Controlled Study

Samsung Medical Center

Status: Enrolling

Conditions: Breast Cancer Lymphedema

Treatments: Device: Medical compression stocking (medical device name: mediven Harmony 734 (compression class1 AG armsleeve or with wide(735))

Study type: Interventional

Funder types: Other

Identifiers

NCT04787029

SMC 2020-11-051

Details and patient eligibility

About

In this study, the purpose of this study is to investigate whether prophylactic medical compression therapy in breast cancer patients receiving docetaxel adjuvant chemotherapy could reduce the incidence and severity of lymphedema in the upper limbs that received axillary lymph node resection (sentinel lymph node biopsy or axillary lymph node dissection).

Enrollment: 150 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients who underwent radical mastectomy and sentinel lymphctomy or axillary lymphectomy after diagnosis of unilateral breast cancer
2. Patients who are scheduled for adjuvant chemotherapy including Docetaxel after surgery
3. Patients aged 19 to 70
4. Patients who can understand the contents of this study and obtain consent

Exclusion criteria

1. Patients with a history of breast-related surgery prior to this breast cancer surgery
2. Patients with metastases to other organs
3. Patients who have undergone neoadjuvant chemotherapy or have previously received radiation therapy
4. Patients with systemic diseases that may not be able to conduct clinical research
5. Patients with skin diseases who cannot receive medical compression treatment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

prophylactic medical compression therapy group

Experimental group

Description:

This study provides medical compression stockings from the start date of Docetaxel administration for patients who have undergone mastectomy and axillary lymphectomy for breast cancer, and who are planning to receive Docetaxel adjuvant chemotherapy. The intervention group wears medical compression stockings for upper limbs with a pressure level of 1 (15-21mmHg) during the day from the start of docetaxel administration to 3 months after the end of administration. Basic education of upper limb exercises (joint motion range enhancement exercises and upper limb muscle pumping exercises) is provided to both the intervention group and the control group.

Treatment:

Device: Medical compression stocking (medical device name: mediven Harmony 734 (compression class1 AG armsleeve or with wide(735))

control group

No Intervention group

Description:

The control group proceeds as an observation, but interventions such as providing stockings in the event of lymphedema are performed. Basic education of upper limb exercises (joint motion range enhancement exercises and upper limb muscle pumping exercises) is provided to both the intervention group and the control group.