The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema
The LYMPH Trial - Comparing Microsurgical With Conservative Treatment of Chronic Breast Cancer Associated Lymphedema: Study Protocol of a Pragmatic Randomized International Multicentre Superiority Trial
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Travel or expenses covered
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Travel or expenses covered
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether surgery to improve lymph fluid drainage leads to better quality of life than treatment without surgery. It is for adults with long-term arm swelling linked to breast cancer. Quality of life will be checked 15 months after people are assigned to a treatment group, about one year after surgery.
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)
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Give written consent to join the study.
- Be at least 18 years old.
- Have had breast cancer.
- Have breast cancer-related lymphedema (swelling from fluid buildup) for more than 3 months, rated stage 1 or higher.
- Have had at least 3 months of treatment without surgery to reduce swelling.
- Be able to fill out surveys about quality of life.
- Be willing to have surgery.
Who can't join
- The treating surgeon decides that lymph fluid drainage surgery is not right for you.
- Have lymphedema that was present at birth or is not linked to breast cancer.
- Have already had surgery for breast cancer-related lymphedema on the side that would be treated.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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. Exclusion Criteria: * 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.
Study sites (4)
CT
- Yale School of Medicine · New Haven, CT 06510Siba Haykal, MD, PhD. · Study contactSiba Haykal, MD, PhD · Principal investigatorMore trials in New Haven
MA
- Harvard Medical School · Boston, MA 02115Andrea Pusic, Prof. Dr. med. · Study contact · +16 17 732 53 61 · apusic@bwh.harvard.eduErin Taylor, Dr. med. · Study contactMore trials in Boston
MO
- Washington University School of Medicine in St. Louis · St Louis, MO 63110Justin M. Sacks, Prof. Dr. · Study contact · +1 314-454-4894 · jmsacks@wustl.eduMore trials in St Louis
NY
- Mayo Clinic · Rochester, NY 55905Vahe Fahrradyan, MD · Study contactVahe Fahrradyan, MD · Principal investigatorMore trials in Rochester