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

Breast Cancer Lymphedema Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04787029
• Other study ID #: SMC 2020-11-051
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2021
• Est. completion date: December 30, 2025

Study information

• Verified date: October 2022
• Source: Samsung Medical Center
• Contact: JIHYE HWANG, Professor
• Phone: 82-10-9933-2816
• Email: jhlee.hwang[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 30, 2025
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema

Intervention

Device:
• Medical compression stocking (medical device name: mediven Harmony 734 (compression class1 AG armsleeve or with wide(735))
Compression stockings worn on the arm or partial swelling of the hand after trauma or surgery.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: excess limb volume (=10%, forearm or whole arm); 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
Primary	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	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	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