The LYMPH Trial - Microsurgical Versus Conservative Treatment of Chronic Breast Cancer Associated Lymphedema

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
University Hospital, Basel, Switzerland
Study ID
NCT05890677
Status
Recruiting
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Conditions

  • Lymphedema, Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Surgical Intervention — PROCEDURE
    LVA (Lymphovenous Anastomosis) and VLNT (Vascularised Lymph Node Transfer) are two advanced microsurgical techniques that are increasingly implemented in clinical practice in specialized centers and that are already carried out after health insurance application according to local standard of care. They have been studied in their respective mode of action as well as in their effectiveness in treating chronic BCRL (Breast Cancer-Related Lymphedema) in a multitude of mostly observational and single center studies with highly encouraging results. Patients in the interventional arm A will receive surgery with one of the two approaches or a combination of both, in a one or two-stage method, at the discretion of the treating surgeon. Depending on local standards one or both of the above might be combined with liposuction to the affected arm in a one or two-stage approach as well.
  • Conservative Complex Physical Decongestion Therapy — PROCEDURE
    Patients randomized to the control arm will receive CDT (Conservative Complex Physical Decongestion Therapy), which currently is considered as the best available standard of care. For this, patients will be referred to one of the dedicated LE (physical/skin) therapy clinics, if not already treated by one, according to their place of residence for continuation of standard conservative therapy. Recommendations to the procedures and treatment frequency of the conservative therapy will be made, but CDT will be done at the discretion of the treating physiotherapist.

Study Details

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)

Key Dates

Start date
Jul 14, 2023
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
Jun 30, 2036

Study Design

Enrollment
280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A : Surgical Group
    According to the pragmatic study design, neither the diagnostic workup nor the surgery will be standardized in order to offer surgeons considerable leeway on how to perform lymphatic surgery, which resembles the flexibility in usual care. The key aspects of the preoperative workup and the surgery including the number of LVAs (Lymphovenous Anastomosis), harvesting of lymph nodes ("donor site"), time of surgery, and practical details will be registered.
  • Active Comparator: Group B: Conservative Complex Physical Decongestion Therapy (control group)
    CDT (Conservative Complex Physical Decongestion Therapy) will be performed as in usual care, following the pragmatic study design. The key aspects like frequency of lymphatic drainage, time when lymphatic drainage is performed and time and class of compressive garments are used will be documented. CDT incorporates two stages of treatment. The first treatment phase (intensive phase) entails skincare, MLD (manual lymphatic drainage), exercises aimed at improvement of mobility/range of motion in the shoulder, elbow or wrist joints, and compression therapy through bandaging. Most patients undergo this phase shortly after the diagnosis of LE. CDT in the second phase (maintenance phase) aims to maintain the achieved limb volume/ circumference reduction through compression with therapeutic elastic compression garment for the arm. Skincare, mobility exercises and MLD is continued in this phase if needed

Primary Outcome Measure

Change in Quality of Life Questionnaire (Lymph-ICF-UL) [ Time Frame: two time assessment at baseline and 15 month after randomization ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Yale School of MedicineNew HavenConnecticut06510
Siba Haykal, MD, PhD.
Siba Haykal, MD, PhD (PRINCIPAL_INVESTIGATOR)
Harvard Medical SchoolBostonMassachusetts02115
Andrea Pusic, Prof. Dr. med.
[email protected]
+16 17 732 53 61
Erin Taylor, Dr. med.
Washington University School of Medicine in St. LouisSt LouisMissouri63110
Justin M. Sacks, Prof. Dr.
[email protected]
+1 314-454-4894
Mayo ClinicRochesterNew York55905
Vahe Fahrradyan, MD
Vahe Fahrradyan, MD (PRINCIPAL_INVESTIGATOR)

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