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Group A : Surgical Group for Lymphedema (LYMPH Trial)

N/A

Recruiting

Led By Elisabeth Kappos, PD Dr. med.

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 15 time assessment up to 10 years after randomization

Awards & highlights

LYMPH Trial 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.Check my eligibility

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.See study design

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.

LYMPH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 13 time assessment up to 10 years after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~13 time assessment up to 10 years after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 13 time assessment up to 10 years after randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Change in Pain score (visual analog scale)

Change in Quality of Life Questionnaire (EuroQol EQ-5D-5L)

Change in Quality of Life Questionnaire (LYMPH-Q)

+1 more

LYMPH 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Swiss National Science FoundationOTHER

222 Previous Clinical Trials

453,612 Total Patients Enrolled

Rising Tide FoundationOTHER

13 Previous Clinical Trials

3,947 Total Patients Enrolled

Krebsforschung Schweiz, Bern, SwitzerlandOTHER

20 Previous Clinical Trials

13,517 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients in this ongoing clinical trial?

"As indicated on clinicaltrials.gov, this research endeavor is actively seeking eligible individuals to partake. The trial's initial posting date was 14th July 2023, with the most recent update dated 7th March 2024."

Answered by AI

Are there several facilities conducting this research in the urban area?

"At present, this study is accepting participants at 31 medical facilities. These sites are dispersed across various regions such as Uppsala, Viganello, and Gent, alongside other undisclosed locations. Opting for the nearest site to your residence could reduce travel commitments when enrolling in the trial."

Answered by AI

What is the number of participants currently involved in this clinical investigation?

"A total of 280 eligible participants are needed to enroll in this research initiative. Patients meeting the defined criteria can choose to engage in the study at various sites, including the Department of Plastic and Reconstructive Surgery at Uppsala University Hospital in Uppsala, Massachusetts, as well as Ospedale Regionale di Lugano in Viganello, Missouri."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The LYMPH Trial - Surgical Versus Conservative Complex Physical Decongestion Therapy for Chronic Breast Cancer-Related Lymphedema

2023. "The LYMPH Trial - Surgical Versus Conservative Complex Physical Decongestion Therapy for Chronic Breast Cancer-Related Lymphedema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05890677.

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