Lymphedema Prevention Program for Breast Cancer
Recruiting in Palo Alto (17 mi)
+6 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Memorial Sloan Kettering Cancer Center
Disqualifiers: Male, Non-English speakers, Axillary recurrence, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
The purpose of this study to test whether a comprehensive program may help the lymph fluid to drain out of the arm and prevent lymphedema in participants with breast cancer.
Do I need to stop taking my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of this treatment for preventing lymphedema in breast cancer patients?
Is Immediate Lymphatic Reconstruction (ILR) safe for preventing lymphedema in breast cancer patients?
Immediate Lymphatic Reconstruction (ILR) is generally considered safe for preventing lymphedema in breast cancer patients, as it is a surgical technique aimed at reducing the risk of developing this condition. However, patients who receive additional treatments like radiotherapy may have an increased risk of lymphedema.12567
How is the treatment Immediate Lymphatic Reconstruction (ILR) unique in preventing lymphedema in breast cancer patients?
Eligibility Criteria
This trial is for women aged 18-75 with breast cancer who are undergoing or may undergo axillary lymph node dissection (ALND). They must be able to consent and speak English. It's not open to men, those allergic to ICG dye used in one of the procedures, patients needing bilateral ALND, those treated with SLNB only, have axillary recurrence or a history of ALND, or have impaired decision-making capacity.Inclusion Criteria
I am female.
I am between 18 and 75 years old.
I have agreed to undergo a specific type of lymph node removal surgery.
See 1 more
Exclusion Criteria
I need both sides of my armpit lymph nodes removed for breast cancer treatment.
I have only had a sentinel lymph node biopsy.
You are allergic to the ICG dye used in the study.
See 5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo axillary lymph node dissection and participate in a comprehensive prevention program to reduce lymphedema
12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment, with arm volume measurements to assess lymphedema development
12 months
Treatment Details
Interventions
- Compression garment use (Behavioural Intervention)
- Immediate Lymphatic Reconstruction (Procedure)
- Lymphatic massage (Behavioural Intervention)
- Range of motion exercises (Behavioural Intervention)
- Volumetric arm measurements (Diagnostic Test)
Trial OverviewThe study tests a comprehensive prevention program that includes lymphatic massage, immediate lymphatic reconstruction surgery (ILR), volumetric arm measurements to track swelling, use of compression garments, and range-of-motion exercises. The goal is to see if these combined efforts can prevent lymphedema after breast cancer surgery.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Participants with Breast CancerExperimental Treatment5 Interventions
Participants will have a diagnosis of breast cancer and may undergo axillary lymph node dissection.
Immediate Lymphatic Reconstruction is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as LYMPHA for:
- Prevention of breast cancer-related lymphedema
🇺🇸 Approved in United States as ILR for:
- Prevention of breast cancer-related lymphedema
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, NJ
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, NJ
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, NY
Memorial Sloan Kettering Nassau (Limited Protocol Activities)Uniondale, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
References
Immediate Lymphatic Reconstruction to Prevent Breast Cancer-Related Lymphedema: A Systematic Review. [2022]Significance: Lymphedema is chronic limb swelling from lymphatic dysfunction. The condition affects up to 250 million people worldwide. In breast cancer patients, lymphedema occurs in 30% who undergo axillary lymph node dissection (ALND). Recent Advances: Immediate lymphatic reconstruction (ILR), also termed Lymphatic Microsurgical Preventing Healing Approach (LyMPHA), is a method to decrease the risk of lymphedema by performing prophylactic lymphovenous anastomoses at the time of ALND. The objective of this study is to assess the risk reduction of ILR in preventing lymphedema. Critical Issues: Lymphedema has significant effects on the quality of life and morbidity of patients. Several techniques have been described to manage lymphedema after development, but prophylactic treatment of lymphedema with ILR may decrease risk of development to 6.6%. Future Directions: Long-term studies that demonstrate efficacy of ILR may allow for prophylactic management of lymphedema in the patient undergoing lymph node dissection.
Mitigating Breast-Cancer-Related Lymphedema-A Calgary Program for Immediate Lymphatic Reconstruction (ILR). [2023]With increasing breast cancer survival rates, one of our contemporary challenges is to improve the quality of life of survivors. Lymphedema affects quality of life on physical, psychological, social and economic levels; however, prevention of lymphedema lags behind the progress seen in other areas of survivorship such as breast reconstruction and fertility preservation. Immediate lymphatic reconstruction (ILR) is a proactive approach to try to prevent lymphedema. We describe in this article essential aspects of the elaboration of an ILR program. The Calgary experience is reviewed with specific focus on team building, technique, operating room logistics and patient follow-up, all viewed through research and education lenses.
Efficacy of Immediate Lymphatic Reconstruction to Decrease Incidence of Breast Cancer-related Lymphedema: Preliminary Results of Randomized Controlled Trial. [2023]To conduct a randomized controlled trial (RCT) on the efficacy of immediate lymphatic reconstruction (ILR) for decreasing the incidence of breast cancer-related lymphedema (BCRL) after axillary lymph node dissection (ALND).
Establishment and Feasibility of an Immediate Lymphatic Reconstruction Program in a Community Health System. [2023]Breast cancer-related lymphedema (BCRL) remains a significant post-surgical complication of breast cancer treatment. Immediate lymphatic reconstruction (ILR) at the time of axillary lymph node dissection (ALND) has shown promise in preventing BCRL. While the primary literature supporting ILR comes from academic institutions, the majority of breast cancer care in the USA occurs in the community setting. This study evaluated a preventative lymphedema program performing ILR at a community health system.
Quantifying radiation in the axillary bed at the site of lymphedema surgical prevention. [2023]Immediate lymphatic reconstruction (ILR) is a procedure known to reduce the risk of lymphedema in patients undergoing axillary lymph node dissection (ALND). However, patients who receive adjuvant radiotherapy are at increased risk of lymphedema. The aim of this study was to quantify the extent of radiation at the site of surgical prevention.
United States insurance coverage of immediate lymphatic reconstruction. [2023]Immediate Lymphatic Reconstruction (ILR) is a prophylactic microsurgical lymphovenous bypass technique developed to prevent breast cancer related lymphedema (BCRL). We investigated current coverage policies for ILR among the top insurance providers in the United States and compared it to our institutional experience with obtaining coverage for ILR.
Assessing the preventive effect of immediate lymphatic reconstruction on the upper extremity lymphedema. [2023]An immediate lymphatic reconstruction (ILR) combining axillary reverse lymphatic mapping (ARLM) and lymphovenous anastomosis (LVA) has been gradually in the spotlight as a novel surgical technique to prevent lymphedema. In this study, we investigate the preventive effect of ILR for the risk of upper extremity lymphedema. We will compare the incidence of postoperative lymphedema between the ILR treatment group and the no-try or failure group during the same period with analysis of the effects of different variables.
Immediate Lymphatic Reconstruction for Prevention of Secondary Lymphedema: A Meta-Analysis. [2022]Secondary lymphedema remains one of the most notorious complications of axillary and pelvic lymph node surgery following mastectomy. There is a lack of high-level evidence found on the effectiveness of immediate lymphatic reconstruction (ILR) in preventing secondary lymphedema. This meta-analysis evaluates the outcomes of ILR for prevention of secondary lymphedema in patients undergoing different surgeries, and provides suggestions for lymphatic microsurgical preventive healing approach (LYMPHA).
Efficacy of Immediate Lymphatic Reconstruction in Prevention of Breast Cancer-Related Lymphedema. [2023]Breast cancer-related lymphedema (BCRL) is a chronic condition that can negatively affect the quality of life of breast cancer survivors. Immediate lymphatic reconstruction (ILR) at the time of axillary lymph node dissection is emerging as a technique for the prevention of BCRL. This study compared the incidence of BRCL in patients who received ILR and those who were not amenable to ILR.