Surgery vs Conservative Therapy for Breast Cancer-Related Lymphedema

(LYMPH Trial)

Recruiting in Palo Alto (17 mi)

+33 other locations

Overseen by Elisabeth Kappos, Prof. Dr.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University Hospital, Basel, Switzerland

Disqualifiers: Primary lymphedema, Non-BCRL, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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)

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is conservative therapy for breast cancer-related lymphedema generally safe?

Conservative treatments like breast conservation therapy, which includes surgery and radiation, are generally safe and have been standard for early-stage breast cancer, with comparable survival rates to more radical surgeries. However, combining these treatments with chemotherapy can increase complications and affect cosmetic outcomes, though it does not impact survival. ^{1 2 3 4 5}

How does Conservative Complex Physical Decongestion Therapy differ from other treatments for breast cancer-related lymphedema?

Conservative Complex Physical Decongestion Therapy (CDT) is unique because it focuses on non-surgical methods to manage lymphedema, using techniques like manual lymph drainage (a type of massage to improve lymph flow), compression bandaging, exercise, and skin care, rather than relying on surgery or medication. ^{2 5 6 7 8}

Research Team

Elisabeth Kappos, Prof. Dr.

Principal Investigator

University Hospital, Basel, Switzerland

Eligibility Criteria

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.

Inclusion Criteria

I am over 18 and have been treated for breast cancer before.

Written informed consent

Minimum of 3 months CDT

Exclusion Criteria

My surgeon decided I don't need surgery for my lymph nodes.

My lymphedema is either present from birth or not caused by breast cancer.

I need urgent surgery for my lymphedema as advised by a specialist.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either lymphatic surgery or conservative complex physical decongestion therapy (CDT) for chronic breast cancer-associated lymphedema

Approximately 1 year

Follow-up

Participants are monitored for safety, effectiveness, and quality of life improvements after treatment

10 years

Treatment Details

Interventions

• Conservative Complex Physical Decongestion Therapy (Procedure)
• Surgical Intervention (Procedure)

Trial Overview 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.

Participant Groups

Group I: Group A : Surgical Group Experimental Treatment 1 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 Control 1 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

Conservative Complex Physical Decongestion Therapy is already approved in European Union, United States, Canada, Switzerland for the following indications:

🇪🇺 Approved in European Union as Complex Physical Decongestive Therapy for:

• Chronic breast cancer-related lymphedema

🇺🇸 Approved in United States as Complex Physical Decongestive Therapy for:

• Chronic breast cancer-related lymphedema

🇨🇦 Approved in Canada as Complex Physical Decongestive Therapy for:

• Chronic breast cancer-related lymphedema

🇨🇭 Approved in Switzerland as Complex Physical Decongestive Therapy for:

• Chronic breast cancer-related lymphedema

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Memorial Sloan Kettering Cancer Center New York, NY

University of British Columbia, Gordon and Leslie Diamond Health Care Centre Vancouver, Canada

Washington University School of Medicine in St. Louis Saint Louis, MO

Harvard Medical School Boston, MA

Who Is Running the Clinical Trial?

University Hospital, Basel, Switzerland

Lead Sponsor

Trials

1031

Patients Recruited

2,503,000+

Swiss National Science Foundation

Collaborator

Trials

227

Patients Recruited

457,000+

Rising Tide Foundation

Collaborator

Trials

17

Patients Recruited

6,200+

Krebsforschung Schweiz, Bern, Switzerland

Collaborator

Trials

21

Patients Recruited

15,300+

Findings from Research

In a study of 150 patients undergoing oncoplastic breast surgery, the use of closed incision negative pressure therapy (ciNPT) significantly reduced postoperative wound healing complications, with a complication rate of 10.3% compared to 31% in the standard of care group.

Patients treated with ciNPT experienced no delays in starting adjuvant therapy, while 22.5% of those receiving standard care faced delays, highlighting ciNPT's potential to improve recovery and treatment timelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Closed Incision Negative Pressure Therapy in Oncoplastic Surgery Prevents Delays to Adjuvant Therapy. Ockerman, KM., Bryan, J., Wiesemann, G., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Local treatment of breast carcinoma: when is breast-saving therapy not indicated?]. Dupont Lampert, V., Zuber, M., Laffer, U., et al.[2017]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

American College of Radiology appropriateness criteria on conservative surgery and radiation: stages I and II breast carcinoma. White, JR., Halberg, FE., Rabinovitch, R., et al.[2008]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conservative surgery, external radiotherapy, and HDR brachytherapy in a single fraction of 7 Gy in early breast cancer: long-term toxicity and esthetic assessment. Rodríguez Pérez, A., López Carrizosa, MC., Samper Ots, PM., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary treatment of early breast cancer with conservation surgery and radiation therapy. The effect of adjuvant chemotherapy. Levitt, SH.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Radiotherapy--an alternative to surgery in the treatment of breast cancer]. Baillet, F.[2006]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status of conservative surgery and radiotherapy as primary local treatment for early carcinoma of the breast. Harris, JR., Recht, A., Schnitt, S., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Esthetic results of the conservative treatment in breast carcinoma]. Moro, G.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Closed Incision Negative Pressure Therapy in Oncoplastic Surgery Prevents Delays to Adjuvant Therapy. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

[Local treatment of breast carcinoma: when is breast-saving therapy not indicated?]. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

American College of Radiology appropriateness criteria on conservative surgery and radiation: stages I and II breast carcinoma. [2008]

4. Italy pubmed.ncbi.nlm.nih.gov

Conservative surgery, external radiotherapy, and HDR brachytherapy in a single fraction of 7 Gy in early breast cancer: long-term toxicity and esthetic assessment. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Primary treatment of early breast cancer with conservation surgery and radiation therapy. The effect of adjuvant chemotherapy. [2019]

6. France pubmed.ncbi.nlm.nih.gov

[Radiotherapy--an alternative to surgery in the treatment of breast cancer]. [2006]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Current status of conservative surgery and radiotherapy as primary local treatment for early carcinoma of the breast. [2019]

8. Italy pubmed.ncbi.nlm.nih.gov

[Esthetic results of the conservative treatment in breast carcinoma]. [2013]