Effectiveness of Lymphovenous Bypass Procedure for Secondary Prevention of Lymphedema in Breast Cancer
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study aims to evaluate the effectiveness of the Lymphovenous Bypass (LVB) procedure compared to physiotherapy alone as secondary prevention of lymphedema in breast cancer patients undergoing axillary lymph node dissection.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Breast cancer patients aged ≥ 18 years with an ECOG score \> 1
• Breast cancer patients with post-axillary lymph node dissection diagnosed with stage 0 and I lymphedema.
• Those who have never undergone lymphedema physiotherapy.
Locations
Other Locations
Indonesia
Dharmais National Cancer Center
RECRUITING
Jakarta
Contact Information
Primary
Adhitya B Perdana, MEpi
adhityabayu@dharmais.co.id
+62 85692445029
Time Frame
Start Date: 2024-03-18
Estimated Completion Date: 2028-03-21
Participants
Target number of participants: 136
Treatments
Experimental: Lymphovenous bypass (LVB)
Sixty-eight subjects will be needed per group. LVB was performed by creating an intima-to-intima anastomosis between the afferent lymphatic vessels and the recipient veins. After surgery, follow-up will be done every 6 months for 2 years. During follow-up, a comprehensive evaluation will be performed, including history and physical examinations, radiological and histopathological examinations, UEL index, ICG lymphography, and quality-of-life evaluation. Each subject will complete the Lymphedema Quality of Life Questionnaire.
No_intervention: Physiotherapy
Sixty-eight subjects will be needed per group. Patients will receive physiotherapy from trained physiotherapists. The protocol includes manual lymphatic drainage (massage techniques), compression, skin care, and arm exercises. Follow-up will be done every 6 months for 2 years. During follow-up, a comprehensive evaluation will be performed, including history and physical examinations, radiological and histopathological examinations, UEL index, ICG lymphography, and quality-of-life evaluation. Each subject will complete the Lymphedema Quality of Life Questionnaire.
Related Therapeutic Areas
Sponsors
Leads: Dharmais National Cancer Center Hospital