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

Primary Purpose

Breast Cancer Lymphedema

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Medical compression stocking (medical device name: mediven Harmony 734 (compression class1 AG armsleeve or with wide(735))
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer Lymphedema

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

prophylactic medical compression therapy group

control group

Arm Description

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.

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

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

Full Information

First Posted
March 1, 2021
Last Updated
October 25, 2022
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04787029
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 12, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Lymphedema

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
prophylactic medical compression therapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Medical compression stocking (medical device name: mediven Harmony 734 (compression class1 AG armsleeve or with wide(735))
Intervention Description
Compression stockings worn on the arm or partial swelling of the hand after trauma or surgery.
Primary Outcome Measure Information:
Title
The cumulative incidence rate of lymphedema (%)
Description
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)
Time Frame
The cumulative incidence of lymphedema during the entire primary observation period
Title
Severity of lymphedema - percentage of excess limb volume (PCEV, ml)
Description
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
Secondary Outcome Measure Information:
Title
ECW/TBW ratio (%) of whole body (body water analysis result)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JIHYE HWANG, Professor
Phone
82-10-9933-2816
Email
jhlee.hwang@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JIHYE HWANG, Professor
Organizational Affiliation
Physical & Rehabilitation Medicine Samsung Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Hye Hwang, MD,PhD
Phone
82-10-9933-2816
Email
jhlee.hwang@skku.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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