Using compression therapy to reduce lymphedema in breast cancer patients receiving chemotherapy
Effect of Prophylactic Medical Compression Therapy on the Reduction of Breast Cancer-related Lymphedema in Patients With Adjuvant Docetaxel Chemotherapy: a Randomized Controlled Study
NA · Samsung Medical Center · NCT04787029
This study is testing if wearing special compression sleeves can help prevent swelling in the arms of breast cancer patients getting chemotherapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 19 Years to 70 Years |
| Sex | All |
| Sponsor | Samsung Medical Center (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04787029 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of prophylactic medical compression therapy in reducing the incidence and severity of lymphedema in breast cancer patients who have undergone axillary lymph node resection and are receiving adjuvant chemotherapy with docetaxel. Participants will be randomized to receive either compression therapy using mediven Harmony 734 sleeves or standard care. The study aims to determine if early intervention with compression therapy can prevent lymphedema in the upper limbs. The trial will include patients aged 19 to 70 who meet specific inclusion criteria related to their breast cancer treatment.
Who should consider this trial
Good fit: Ideal candidates are breast cancer patients aged 19 to 70 who have undergone surgery and are scheduled to receive adjuvant docetaxel chemotherapy.
Not a fit: Patients with a history of prior breast-related surgery, metastases, or systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk and severity of lymphedema in breast cancer patients undergoing chemotherapy.
How similar studies have performed: While there is limited data on this specific approach, similar studies have shown promise in using compression therapy for lymphedema management.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, Korea, Republic of (RECRUITING)
Study contacts
- Study coordinator: JIHYE HWANG, Professor
- Email: jhlee.hwang@samsung.com
- Phone: 82-10-9933-2816
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer Lymphedema