Surgery vs Conservative Therapy for Breast Cancer-Related Lymphedema
(LYMPH Trial)
Recruiting in Palo Alto (17 mi)
+33 other locations
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.12345
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.25678
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
See 3 more
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 OverviewThe 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
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
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 NearbySelect from list below to view details:
Memorial Sloan Kettering Cancer CenterNew York, NY
University of British Columbia, Gordon and Leslie Diamond Health Care CentreVancouver, Canada
Washington University School of Medicine in St. LouisSaint Louis, MO
Harvard Medical SchoolBoston, MA
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Who Is Running the Clinical Trial?
University Hospital, Basel, SwitzerlandLead Sponsor
Swiss National Science FoundationCollaborator
Rising Tide FoundationCollaborator
Krebsforschung Schweiz, Bern, SwitzerlandCollaborator
References
Closed Incision Negative Pressure Therapy in Oncoplastic Surgery Prevents Delays to Adjuvant Therapy. [2023]Breast reductions, including oncoplastic breast surgery (OBS), have high postoperative wound healing complication (WHC) rates, ranging from 17% to 63%, thus posing a potential delay in the onset of adjuvant therapy. Incision management with closed incision negative pressure therapy (ciNPT) effectively reduces postoperative complications in other indications. This retrospective analysis compares postoperative outcomes and delays in adjuvant therapy in patients who received ciNPT on the cancer breast versus standard of care (SOC) after oncoplastic breast reduction and mastopexy post lumpectomy.
[Local treatment of breast carcinoma: when is breast-saving therapy not indicated?]. [2017]Conservative treatment of breast cancer is now an accepted oncological procedure. It further allows a good functional and cosmetic result. This treatment needs more skills and time than mastectomy, as it does not only include a surgical excision but also a postoperative local radiotherapy and a sometimes difficult follow-up during many years. The contraindications for conservative breast cancer therapy are numerous and depend on factors as tumor, patient and radiotherapy. As more than 1100 patients have been treated since 1977 in our area at a single radiooncological center by a breast conserving procedure. We have confirmed or defined criteria which lead to a good local tumor control as well as to good functional and cosmetic results.
American College of Radiology appropriateness criteria on conservative surgery and radiation: stages I and II breast carcinoma. [2008]During the past 2 decades, breast conservation therapy (BCT) has become firmly established as a standard therapeutic approach for eligible women with early-stage breast cancer. Breast radiation after conservative surgery is an integral component of BCT, resulting in comparable local control and equivalent survival to mastectomy. Successful breast conservation relies on understanding key elements for patient selection, evaluation, treatment contraindications, radiation therapy methods, and integration with systemic therapy.
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]The essential issue in conservative treatment is the quality in breast preservation. When risk factors for local relapse exist, a tumour bed boost is required, but the boost choice remains controversial. Prospectively, we studied long-term toxicity, cosmetic outcome and prognostic factors.
Primary treatment of early breast cancer with conservation surgery and radiation therapy. The effect of adjuvant chemotherapy. [2019]The combination of radiation therapy (RT) and conservation surgery is appropriate treatment for Stage I and II breast cancer patients, and is equivalent to radical mastectomy in overall survival and recurrence free survival. Moreover, RT and conservation surgery has the advantage over radical surgery of breast preservation (and subsequent psychological advantage). Inherent in the preservation of the breast is the concept of cosmesis. This implies that the treated breast is not retracted or deformed by the surgery and radiation. Current studies indicate that there is an increase in complications and less satisfactory cosmetic effect on patients receiving chemotherapy in conjunction with conservation surgery and RT, but no effect on survival. This raises the question of which patients should receive chemotherapy and what type of chemotherapy should be used. It also raises the question of the initiation timing and dosage of chemotherapy.
[Radiotherapy--an alternative to surgery in the treatment of breast cancer]. [2006]Patients with breast cancer are treated with radiotherapy alone for one of three reasons: either surgery is impossible (inoperable cases due to locoregional extension, patient status, patient refusal), there is an undeniable benefit (metastasis at diagnosis) or a conservative treatment would be possible if surgery is avoided (which, in France, is currently the case for operable tumours larger than 3 cm inaccessible to a combination tumorectomy/radiotherapy). Radiotherapy can also be used instead of surgery to reach an identical satisfactory result; i.e. locoregional control of the cancer and an aesthetic result of satisfactory quality. Actually, when the alternative offers a real benefit for the patient, radiotherapy alone should be entertained, particularly for tumours classically treated by primary mastectomy (T > 3 cm). For a long time, it was difficult to achieve both efficacity and good tolerance with radiotherapy. In addition, one could not be certain that survival rates were the same for conservative and radical treatments. But since then, randomized and non-randomized comparisons have shown that the conservative or radical nature of the treatment has no effect on survival. Radiotherapy is now better tolerated due to lower total doses which were sometimes too high due to the unjustified reputation of radioresistance. Radiotherapy is thus an alternative to surgery in operable cases, offering conservative treatment and the possibility of delayed surgery if needed. Thus one cannot speak of treatment without surgery since an operation is programmed if required. The treatment can also begin with routine axillary dissection both as a therapeutic and diagnostic procedure.(ABSTRACT TRUNCATED AT 250 WORDS)
Current status of conservative surgery and radiotherapy as primary local treatment for early carcinoma of the breast. [2019]Since it is now recognized that breast cancer is commonly a systemic disease at presentation, it is clear that local treatment is limited to providing local tumor control, and that effective systemic therapy is required for the eradication of micrometastatic disease. We here review the current status of conservative surgery and radiotherapy in the treatment of early breast cancer. Results from retrospective studies support the view that this combination is highly effective in achieving local control and maintaining good cosmetic results. Results at five and ten years from prospective trials indicate that survival using this approach is comparable to that of mastectomy. Though further follow-up is required, we do not believe that a large survival difference in favor of either approach will emerge.
[Esthetic results of the conservative treatment in breast carcinoma]. [2013]To assess the factors affecting cosmetic results after conservative breast cancer treatment, the findings of 164 patients submitted to conservative surgery plus radiotherapy 1988 to 1992, were reviewed. Surgery, except for one wider excision, consisted in quadrantectomy; the whole breast was given 50 Gy with telecobalt therapy and the 10-Gy boost on the surgical bed was administered with a Roentgen therapy unit. In 119 patients hormone therapy and/or chemotherapy were combined. The middle and median follow-up rates were 43.2 and 38 months, respectively. Outcomes were graded as excellent, satisfactory and poor (on the basis of asymmetry, volume loss and nipple retraction) and correlated with the Stepwise Logistic Regression method with patients' age, tumor size and site, combined chemotherapy and/or hormone therapy, surgical technique (axillary "en bloc" dissection) and surgery department. Lower external quadrant site, surgery department and some combined treatments (CMF and anthracycline plus Tamoxifen) bore a major influence on prognosis. Lower external quadrant site as a factor influencing treatment outcome is not reported in similar literature studies. Different treatment results in different surgery departments are certainly not related to different surgical techniques. The influence of combined adjuvant treatments on cosmetic results, related to the interaction with radiation damage repair, may worsen the cosmetic result, which is one of the main goals of conservative treatment. We hope that the whole treatment course (surgery, irradiation, medical treatment) can be customized to lesion characteristics and to patient's needs.