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

NCT ID: NCT04787029

Last Updated: 2022-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-12

Study Completion Date

2025-12-30

Brief Summary

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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).

Detailed Description

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Conditions

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Breast Cancer Lymphedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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prophylactic medical compression therapy group

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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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JiHye Hwang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JIHYE HWANG, Professor

Role: STUDY_CHAIR

Physical & Rehabilitation Medicine Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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JIHYE HWANG, Professor

Role: CONTACT

82-10-9933-2816

Facility Contacts

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Ji Hye Hwang, MD,PhD

Role: primary

82-10-9933-2816

Other Identifiers

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SMC 2020-11-051

Identifier Type: -

Identifier Source: org_study_id

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