Lymphedema of Upper Limb Clinical Trial
Official title:
Effectiveness and Cost-effectiveness of Lymphaticovenous Anastomosis for Cancer Patients Who Suffer From Chronic Peripheral Lymphedema: a Randomized Controlled Trial
The goal of this randomized controlled trial is to compare the effectiveness and cost-effectiveness of lymphaticovenous anastomosis (LVA) with sham surgery for patients suffering from unilateral cancer-related lymphedema in either the upper or lower extremity. It aims to answer whether LVA is more effective than sham surgery in terms of improvement in Lymph-ICF score. A total of 110 participants will be allocated randomly into two groups at a 1:1 ratio. The first group will receive lymphaticovenous anastomosis (LVA), while the second group will undergo sham surgery.
One of the most debilitating side effects of cancer treatment is cancer-related lymphedema (CRL), with an overall incidence of 15.5%. To date, there is no definite cure for lymphedema. Conservative therapy, namely complex decongestive therapy is the golden standard for the treatment. Lymphaticovenous anastomosis (LVA) might be a promising treatment modality for patients with CRL, but available studies are small and the quality is lacking. No large-scale prospective or randomized studies have been published on the efficacy of LVA. The main objective of this randomized controlled trial is to assess whether LVA is more effective than sham surgery in terms of improvement in Lymph-ICF score, volume reduction, reduction of complex decongestive therapy, and cost-effectiveness. The study will take place in three centers in the Netherlands: Maastricht University Medical Center, Radboud University Medical Center, and Erasmus University Medical Center. The patients will be randomly distributed into two groups: the LVA group or the Sham group. Both procedures are performed under local anesthesia. Patients in both groups are subject to minor surgical complications (wound infection, bleeding, wound dehiscence). Special care will be taken to prevent damage to lymphatic vessels in the Sham group, to allow a future LVA operation once the study ends. The follow-up moments will be at 3, 6, 12, 18, and 24 months. Additionally, a subset of patients will partake in an annual extended follow-up, ongoing until the start of the analysis. Each follow-up moment will last 45 minutes in total. The patient also receives two digital questionnaires at each follow-up moment. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04858230 -
LymphoPilot Test for Limb Lymphedema
|
N/A | |
Completed |
NCT04575636 -
MRL in the Upper Extremity
|
N/A | |
Completed |
NCT03252145 -
Treatment of Breast Cancer-related Lymphedema With a Negative Pressure Device
|
N/A | |
Active, not recruiting |
NCT05441943 -
Lymphaticovenous Anastomosis as Treatment for Lymphedema
|
N/A | |
Completed |
NCT05754346 -
Does Inclusion of Diaphragmatic Breathing Exercises in Complete Decongestive Therapy Provide Further Benefits in Patients With Breast Cancer Related Lymphedema
|
N/A | |
Completed |
NCT06399458 -
The Relationship Between Primary Lymphedema and Joint Hypermobility
|
||
Not yet recruiting |
NCT06264817 -
Auto-Adjustable MOBIDERm Autofit Armsleeve in the Management of Upper Limb Lymphedema.
|
N/A | |
Recruiting |
NCT06302361 -
Lymphovenous Anastomosis for Breast Cancer Lymphedema
|
N/A | |
Active, not recruiting |
NCT06278298 -
Different Level of ECSWT in Post Mastectomy Lymphedema
|
N/A | |
Completed |
NCT05037708 -
Effects of Physiotherapy in the Treatment of Lymphedema After Breast Cancer
|
N/A | |
Not yet recruiting |
NCT02453295 -
Testing an Intervention to Foster Hope for Cancer Survivors With Lymphedema
|
N/A | |
Completed |
NCT05660590 -
Effect of Different Bandage Interface Pressures on Breast Cancer Related Lymphedema
|
N/A | |
Withdrawn |
NCT02458391 -
Complete Decongestive Therapy in Breast Cancer-Related Lymphedema
|
N/A | |
Completed |
NCT04766489 -
Evaluation of the Treatment Response in Breast Cancer Related Lymphedema
|
N/A | |
Enrolling by invitation |
NCT04165512 -
Effectiveness of Stellate Ganglion Block in Breast Cancer Related Lymphedema
|
N/A | |
Recruiting |
NCT05762224 -
Comparative Effects of KT and PG on UE Lymphedema and Functional Disability After Mastectomy
|
N/A | |
Recruiting |
NCT05142800 -
Screening For BCRL In Targeted Therapy For Breast Cancer
|
||
Recruiting |
NCT06012786 -
Myofascial Pain Syndrome in Patients With Breast Cancer-related Lymphedema
|
||
Not yet recruiting |
NCT06113627 -
Lymphatic Response to Resistance Exercise in Breast Cancer Survivors
|
N/A | |
Completed |
NCT06036173 -
Body Awareness and Functionality in Lymphedema
|