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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
150
Compression stockings worn on the arm or partial swelling of the hand after trauma or surgery.
Samsung Medical Center
Seoul, South Korea
RECRUITINGThe cumulative incidence rate of lymphedema (%)
The cumulative incidence rate of lymphedema The cumulative incidence of lymphedema during the entire primary observation period (Enrollment (pre-docetaxcel), mid-docetaxcel(up to 20 weeks), Post-docetaxcel 1month, Post-docetaxcel 3month, Post-docetaxcel, 6month, Post-docetaxcel, 1year, Post-docetaxcel, 1.5year, Post-docetaxcel 2year) permanent lymphedema criteria: 1. excess limb volume (≥10%, forearm or whole arm) 2. excess limb volume (\<10%, forearm or whole arm, If there is regional lymphedema suitable for lymphatic territory and a Lymphedema specialist makes a clinical diagnosis)
Time frame: The cumulative incidence of lymphedema during the entire primary observation period
Severity of lymphedema - percentage of excess limb volume (PCEV, ml)
Limb lymphedema volumes were measured using the electronic volumeter device (Perometer; Pero-System, Wuppertal, Germany), which is an optoelectronic instrument for measuring limb volume and circumferences. PCEV (%) = \[(volume of affected limb - volume of unaffected limb) / volume of unaffected limb\] × 100 Volume comparison between groups at the onset of lymphedema during the follow-up period (Enrollment (pre-docetaxcel), mid-docetaxcel(up to 20 weeks), Post-docetaxcel 1month, Post-docetaxcel 3month, Post-docetaxcel, 6month, Post-docetaxcel, 1year, Post-docetaxcel, 1.5year, Post-docetaxcel 2year)
Time frame: Time of occurrence of lymphedema during the follow-up period
ECW/TBW ratio (%) of whole body (body water analysis result)
This ratio will be measured using Inbody scale (S10) on each observation period and this trend will be analyzed by time, group and interaction
Time frame: Enrollment (pre-docetaxcel), mid-docetaxcel(up to 20 weeks), Post-docetaxcel 1month, Post-docetaxcel 3month, Post-docetaxcel, 6month, Post-docetaxcel, 1year, Post-docetaxcel, 1.5year, Post-docetaxcel 2year
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