BridgeMD
Compares treatment options for Lymphedema, Breast Cancer
Official title The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema
ClinicalTrials.gov ID: NCT05890677
What this study is testing
- What it's testing
- The aim of this study is to test whether lymphatic surgery provides better QoL (assessed with the Lymph-ICF-UL, (Lymphedema Functioning Disability and health questionnaire for upper limb lymphedema)) 15 months after randomization (and therefore about one year after surgery) compared to conservative treatment only for patients with chronic lymphedema (LE)
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Written informed consent.
- Patients ≥ 18 years of age.
- Former diagnosis of breast cancer.
- Clinical diagnosis of chronic Breast Cancer-Related Lymphedema (BCRL) (persisting for more than 3 months) classified as ≥ Stage 1, according to ISL.
- Minimum of 3 months Conservative Complex Physical Decongestion Therapy.
You likely can't join if
- No indication for lymphatic surgery according to clinical judgment of the treating surgeon (individual reasons will be specifically documented).
- Primary congenital Lymphedema or non-BCRL.
- Previous surgical BCRL treatment on the side intended for intervention.
See the full eligibility criteria
- Written informed consent.
- Patients ≥ 18 years of age.
- Former diagnosis of breast cancer.
- Clinical diagnosis of chronic Breast Cancer-Related Lymphedema (BCRL) (persisting for more than 3 months) classified as ≥ Stage 1, according to ISL.
- Minimum of 3 months Conservative Complex Physical Decongestion Therapy.
- Ability to complete the QoL questionnaires.
- Willingness to undergo surgery.
- No indication for lymphatic surgery according to clinical judgment of the treating surgeon (individual reasons will be specifically documented).
- Primary congenital Lymphedema or non-BCRL.
- Previous surgical BCRL treatment on the side intended for intervention.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Rochester, New York, United States
- Sankt Pölten, Lower Austria, Austria
- Vienna, State of Vienna, Austria
- Brussels, Jette, Belgium
- Ghent, Belgium
- Paraná, Curitiba, Brazil
- Montreal, Canada
- Vancouver, Canada
- Bochum, Germany
- Düsseldorf, Germany
- Erlangen, Germany
- Essen, Germany
- Frankfurt, Germany
- Freiburg im Breisgau, Germany
- Ludwigshafen am Rhein, Germany
- Nuremberg, Germany
- Regensburg, Germany
+ 15 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Boston, Massachusetts, United States; St Louis, Missouri, United States; Rochester, New York, United States; Sankt Pölten, Lower Austria, Austria; Vienna, State of Vienna, Austria and 29 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.