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Surgery vs Conservative Therapy for Breast Cancer-Related Lymphedema (LYMPH Trial)

N/A

Recruiting

Led By Elisabeth Kappos, Prof. Dr.

Research Sponsored by University Hospital, Basel, Switzerland

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 time assessment up to 2 years after randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to investigate if surgery for lymphedema improves quality of life compared to conservative treatment for patients with chronic lymphedema. They will assess quality of life using a specific questionnaire 15 months

Who is the study for?

This trial is for adults over 18 who've had breast cancer treatment (like lymph node removal or radiotherapy) and now have chronic swelling in their arms, known as lymphedema. They should have tried decongestion therapy for at least 3 months and be able to fill out quality of life surveys.

What is being tested?

The LYMPH Trial is comparing two ways to treat arm swelling after breast cancer: standard physical therapy versus surgery. The goal is to see which method improves patients' quality of life better one year after the treatment.

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical risks associated with surgical procedures such as infection, pain, scarring, and complications from anesthesia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 time assessment up to 2 years after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 time assessment up to 2 years after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 time assessment up to 2 years after randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Assessment of (serious) adverse events

Assessment of arm volume

Assessment of lymphangitic events (erysipelas)

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group A : Surgical GroupExperimental Treatment1 Intervention

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.

Group II: Group B: Conservative Complex Physical Decongestion Therapy (control group)Active Control1 Intervention

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

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