RightFit
RecruitingNot applicable

ILR to Prevent BRCL_MCC 23608

Prospective, Randomized Clinical Trial for Immediate Lymphatic Reconstruction to Prevent Breast Cancer Related Lymphedema

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years, 12 months, 24 months
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "At the 2-week postoperative visit, participants will be further randomized into two postoperative monitoring protocols: BCRL Clinical Pathway: Patients will have regular follow-up visits every three months for two years, including repeat BIS, limb measurements, perometry, and quality of life questionnaires (LYMQOL and ULL-27)."
  • "Enrollment will last for 12 months."
  • "Patients randomized to postoperative monitoring via the BRCL Clinical Pathway will be seen every three months postoperatively for 24 months."
  • "The decision for two years was decided to encompass when the risk for the development of BCRL peaks around 6-12 months after ALND."
  • "Patients are also asked to complete patient reported outcomes questionnaires, including LYMQOL (Lymphoedema Quality of Life) and ULL-27 (Upper Limb Lymphedema 27)."
  • "The LYMQOL and ULL-27 questionnaires will be utilized to assess quality of life and patient reported symptoms of BCRL."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether connecting lymph vessels to nearby veins during underarm lymph node surgery can prevent lymphedema, or swelling caused by fluid buildup. It is for women ages 18–75 with breast cancer who are at high risk for this swelling. The study also checks safety and quality of life.

The goal of this clinical trial is to evaluate the effectiveness of Immediate Lymphatic Reconstruction (ILR) in preventing breast cancer-related lymphedema (BCRL) in high-risk patients. It will also assess the safety and quality of life outcomes associated with the procedure. The main questions it aims to answer are: Does ILR reduce the incidence of BCRL in patients undergoing axillary lymph node dissection (ALND)? What are the patient-reported outcomes and quality of life differences between those who receive ILR and those who do not? Participants will be identified as high-risk for developing BCRL through a multidisciplinary tumor board and referred to a specialized clinic for further evaluation. High-risk patients will undergo a series of screening tests, including bioimpedance spectroscopy (BIS), circumferential limb measurements, and infrared 3D perometry. Participants will be randomly assigned to one of two groups: Intervention Group (Study Arm A): Undergo ILR during ALND surgery, where preserved lymphatic channels are connected to nearby veins to prevent lymphedema. Control Group (Study Arm B): Will not receive ILR, but efforts will be made to preserve lymphatic channels during surgery. Patients will be blinded to their group assignment. Post-surgery, all participants will receive education from a certified lymphatic physical therapist. At the 2-week postoperative visit, participants will be further randomized into two postoperative monitoring protocols: BCRL Clinical Pathway: Patients will have regular follow-up visits every three months for two years, including repeat BIS, limb measurements, perometry, and quality of life questionnaires (LYMQOL and ULL-27). Standard of Care: Patients will be monitored only if they experience BCRL symptoms or after two years from ALND. The study will compare the outcomes of both groups, with a focus on the incidence of BCRL and patient quality of life, and will benchmark these results against published literature on breast cancer patients.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women ages 18–75 who have breast cancer.
  • Agree to have underarm lymph nodes removed on one side (ALND). A past sentinel node biopsy is allowed if it was less than 6 months before consent.
  • Or, agree to a sentinel node biopsy, which removes the first nodes cancer may reach, with possible ALND. A node must show signs of cancer on an exam or scan, or the breast surgeon must think ALND is very likely.
  • During ALND, the surgeon must find at least one cut lymph vessel and one vein that can be connected.

Who can't join

  • Men with breast cancer, or people who do not speak English.
  • Breast cancer that has returned in the underarm, or cancer that has spread to distant parts of the body at screening.
  • Past ALND, need for ALND on both sides, or treatment with only a sentinel node biopsy.
  • Fluid buildup or swelling already present in the affected arm before lymph node removal, whether present from birth or caused later.
  • Past radiation treatment to the underarm before the study or surgery.
  • Expected to live less than 2 years for any reason.
  • Pregnant or breastfeeding.
  • Alcohol or drug abuse within 6 months before screening, or severe mental illness.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Patients consenting for unilateral ALND \[prior history of sentinel lymph node biopsy (SLNBx) allowed if \<6 months from consent\] * Patients consenting for unilateral SLNBx with possible ALND, with a clinically or radiographically positive lymph node OR a high likelihood of ALND per the Breast Surgeon * Identification of at least one transected lymphatic channel and at least one vein to be used for bypass at the time of ALND during surgery * Female breast cancer patients 18-75 years of age (inclusive) Exclusion Criteria: * • Male breast cancer patients * Non-English speaking participants * Female breast cancer patients with axillary recurrence * Female breast cancer patients who have a history of ALND * Female patients requiring bilateral ALND for the treatment of their breast cancer * Female breast patients treated with SLNBx only * Primary lymphedema of the affected upper limb * Secondary lymphedema of the affected limb prior to the lymphadenectomy * Radiotherapy at the axilla before the study / surgery * Life expectancy \< 2 years for any reason * Pregnancy or nursing * Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening * Severe psychiatric disease * Distant metastases at the time of preoperative screening

Study sites (3)

FL