NCT05890677 The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema
| NCT ID | NCT05890677 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Lymphedema, Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2023-07-14 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 280 participants in total. It began in 2023-07-14 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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)
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.
Contact & Investigator
Elisabeth Kappos, Prof. Dr.
PRINCIPAL INVESTIGATOR
University Hospital, Basel, Switzerland
Frequently Asked Questions
Who can join the NCT05890677 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lymphedema, Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05890677 currently recruiting?
Yes, NCT05890677 is actively recruiting participants. Contact the research team at elisabeth.kappos@usb.ch for enrollment information.
Where is the NCT05890677 trial being conducted?
This trial is being conducted at New Haven, United States, Boston, United States, St Louis, United States, Rochester, United States and 11 additional locations.
Who is sponsoring the NCT05890677 clinical trial?
NCT05890677 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Elisabeth Kappos, Prof. Dr. at University Hospital, Basel, Switzerland. The trial plans to enroll 280 participants.
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