Surgery vs Conservative Therapy for Breast Cancer-Related Lymphedema

(LYMPH Trial)

Recruiting at 33 trial locations

Overseen By Elisabeth Kappos, Prof. Dr.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Hospital, Basel, Switzerland

Disqualifiers: Primary lymphedema, Non-BCRL, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 1 year

280 Participants Needed

What You Need to Know Before You Apply

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}

Who Is on the Research Team?

Elisabeth Kappos, Prof. Dr.

Principal Investigator

University Hospital, Basel, Switzerland

Are You a Good Fit for This Trial?

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

Written informed consent

Minimum of 3 months CDT

I have had swelling in one limb for more than 3 months, and it's significantly larger than the other.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Conservative Complex Physical Decongestion Therapy
• Surgical Intervention

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

University Hospital, Basel, Switzerland

Lead Sponsor

Trials

1,031

Recruited

2,503,000+

Swiss National Science Foundation

Collaborator

Trials

227

Recruited

457,000+

Rising Tide Foundation

Collaborator

Trials

17

Recruited

6,200+

Krebsforschung Schweiz, Bern, Switzerland

Collaborator

Trials

21

Recruited

15,300+

Published Research Related to This Trial

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]

Conservative treatment for breast cancer, which includes surgical excision followed by local radiotherapy, has been shown to provide good functional and cosmetic outcomes for patients, as evidenced by over 1100 cases treated since 1977.

The study identified specific criteria that contribute to effective local tumor control and positive results, highlighting the importance of careful patient selection and management in conservative breast cancer therapy.

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]

Breast conservation therapy (BCT) is now a standard treatment for early-stage breast cancer, providing similar local control and survival rates as mastectomy, especially when combined with radiation therapy after surgery.

The American College of Radiology's expert panel established updated guidelines for BCT, addressing various clinical scenarios and factors such as patient age, tumor characteristics, and radiation methods to optimize treatment outcomes.

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]

In a study of 115 patients receiving a 7 Gy HDR-brachytherapy boost after conservative breast cancer treatment, the cosmetic outcomes were rated as satisfactory by 96% of patients and 85% of physicians, indicating good aesthetic results despite some reported side effects.

Late toxicity was observed in the form of breast pain (39%), fibrosis (75%), and telangiectasias (56%), but overall, the HDR-brachytherapy boost was associated with acceptable levels of toxicity, suggesting it is a viable option for enhancing breast preservation in patients with local relapse risk.

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]

The combination of radiation therapy and conservation surgery for Stage I and II breast cancer patients provides similar overall survival and recurrence-free survival rates as radical mastectomy, while also allowing for breast preservation, which can have psychological benefits.

Current studies suggest that adding chemotherapy to conservation surgery and radiation therapy may lead to increased complications and poorer cosmetic outcomes, but it does not affect survival, prompting further investigation into the appropriate use and timing of chemotherapy in these patients.

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]

Radiotherapy can be an effective alternative to surgery for breast cancer treatment, especially in cases where surgery is not possible or when it can provide similar outcomes in terms of cancer control and aesthetic results, particularly for larger tumors (T > 3 cm).

Recent studies indicate that the type of treatment (conservative vs. radical) does not significantly affect survival rates, and advancements in radiotherapy have improved its tolerability, allowing for lower doses and making it a viable option for patients who may eventually require surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Conservative surgery combined with radiotherapy is effective for local control of early breast cancer and maintains good cosmetic outcomes, as supported by retrospective studies.

Long-term survival rates at five and ten years show that this approach is comparable to mastectomy, suggesting that significant survival differences between the two methods are unlikely to emerge with further follow-up.

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]

In a review of 164 patients who underwent conservative breast cancer treatment, factors such as the tumor's location in the lower external quadrant and the type of adjuvant therapy significantly influenced cosmetic outcomes after surgery and radiotherapy.

The study found that certain combined treatments, like CMF and anthracycline plus Tamoxifen, may negatively impact cosmetic results, highlighting the need for personalized treatment plans that consider both the cancer characteristics and the patient's preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Citations

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]