Back to resultsEffect 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
About this trial
This is an interventional prevention trial for Breast Cancer Lymphedema
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
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
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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