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New treatment option for Breast Cancer Lymphedema
Official title ILR to Prevent BRCL_MCC 23608
ClinicalTrials.gov ID: NCT07127003
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- 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...
- 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)
You likely can't join if
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.