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
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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RECRUITING
NA
150 participants
INTERVENTIONAL
2021-03-12
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
70 Years
ALL
Yes
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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JiHye Hwang
Professor
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SMC 2020-11-051
Identifier Type: -
Identifier Source: org_study_id
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