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 | Unknown

• 1 other identifier: SMC 2020-11-051
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer Lymphedema

Outcome Measures

Primary Outcomes (2)

• The 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)

  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 of occurrence of lymphedema during the follow-up period

Secondary Outcomes (1)

• ECW/TBW ratio (%) of whole body (body water analysis result)

  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

Study Arms (2)

prophylactic medical compression therapy group

EXPERIMENTAL

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.

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

control group

NO INTERVENTION

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.

Interventions

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

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

prophylactic medical compression therapy group

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• JIHYE HWANG, Professor

  Physical & Rehabilitation Medicine Samsung Medical Center

  STUDY CHAIR

Central Study Contacts

JIHYE HWANG, Professor

CONTACT

82-10-9933-2816; jhlee.hwang@samsung.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 8, 2021
• Study Start: March 12, 2021
• Primary Completion: April 30, 2023
• Study Completion: December 30, 2025
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

KR (1)