Comparing compression sleeves to routine care for preventing lymphedema in breast cancer patients
Comparing Level 1 Compression Sleeves With Routine Care in Preventing Breast Cancer-related Arm Lymphedema :An Open-label, Single-center, Randomized Controlled Phase II Clinical Trial
NA · Henan Cancer Hospital · NCT06095323
This study tests if wearing compression sleeves can help prevent arm swelling in breast cancer patients who have had surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 480 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Henan Cancer Hospital (other gov) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT06095323 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of Level 1 compression sleeves in preventing breast cancer-related arm lymphedema compared to routine care. It involves patients aged 18 to 70 who have undergone axillary lymph node dissection due to unilateral breast cancer. Participants will be monitored for arm swelling using bioimpedance spectroscopy and limb circumference measurements. The study seeks to determine if wearing compression sleeves can significantly reduce the incidence of lymphedema, a common complication affecting quality of life.
Who should consider this trial
Good fit: Ideal candidates are breast cancer patients aged 18 to 70 who have undergone axillary lymph node dissection.
Not a fit: Patients with pre-existing arm swelling, upper limb dysfunction, or bilateral breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method to significantly reduce the risk of lymphedema in breast cancer patients, improving their quality of life.
How similar studies have performed: Other studies have shown promising results with similar non-surgical approaches to prevent lymphedema, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 18 to 70 years old 2. Breast cancer, unilateral，Patients undergoing axillary lymph node dissection 3. Patients voluntarily joined the study and signed informed consent Exclusion Criteria: 1. arm swelling preoperatively, as assessed by bioimpedance spectroscopy (BIS) or Limb circumference measurement 2. any condition that hindered them from wearing a compression sleeve 3. Patients with upper limb dysfunction before surgery, including shoulder and elbow joint mobility disorders 4. Patients with mental disorders, senile dementia, and cognitive impairments，were not able to complete a questionnaire independently 5. Patients with bilateral breast cancer, recurrence, or metastasis to other organs.
Where this trial is running
Zhengzhou, Henan
- Henan Cancer Hospital — Zhengzhou, Henan, China (RECRUITING)
Study contacts
- Principal investigator: Zhenzhen Liu — Henan Cancer Hospital
- Study coordinator: Zhenzhen Liu
- Email: liuzhenzhen73@126.com
- Phone: 13603862755
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-related Arm Lymphedema, breast cancer-related arm lymphedema, bioimpedance spectroscopy, Limb circumference measurement