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NCT04787029 | RECRUITING | Breast Cancer Lymphedema

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

Samsung Medical Center

Information provided by (Responsible Party):

J IH also h.com

Brief Summary:

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).

Condition or disease

Breast Cancer Lymphedema

Intervention/treatment

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

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Effect of Prophylactic Medical Compression Therapy on the Reduction of Breast Cancer-related Lymphedema in Patients With Adjuvant Docetaxel Chemotherapy: a Randomized Controlled Study
Actual Study Start Date : 2021-03-12
Estimated Primary Completion Date : 2023-04-30
Estimated Study Completion Date : 2025-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 19 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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
Effect of Prophylactic Medical Compression Therapy on the Reduction of Breast Cancer-related Lymphedema in Patients With Adjuvant Docetaxel Chemotherapy: a Randomized Controlled Study

Location Details

NCT04787029

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Korea, Republic of,

Samsung Medical Center

Seoul, Korea, Republic of,