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Docetaxel

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.

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.

Compression stockings worn on the arm or partial swelling of the hand after trauma or surgery.

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

JIHYE HWANG, Professor

Ji Hye Hwang, MD,PhD

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).

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

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)

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)

This ratio will be measured using Inbody scale (S10) on each observation period and this trend will be analyzed by time, group and interaction

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effect of Prophylactic Medical Compression Therapy on the Reduction of Breast Cancer-related Lymphedema in Patients With Adjuvant Docetaxel Chemotherapy: a Randomized Controlled Study	NCT04787029	Breast Cancer L...	Medical compres...	19 Years - 70 Years	Samsung Medical Center
Effect of Prophylactic Medical Compression Therapy on the Reduction of Breast Cancer-related Lymphedema in Patients With Adjuvant Docetaxel Chemotherapy: a Randomized Controlled Study	NCT04787029	Breast Cancer L...	Medical compres...	19 Years - 70 Years	Samsung Medical Center

Spots Global Cancer Trial Database for medical compression stocking (medical device name: mediven harmony 734 (compression class1 ag armsleeve or with wide(735))