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Procedure
Lymphovenous Bypass Procedure for Breast Cancer
N/A
Recruiting
Led By Mark Schaverien
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial studies whether a surgical procedure called lymphovenous bypass can prevent arm swelling in patients with certain types of breast cancer or melanoma. The surgery creates a new path for fluid to move away from the arms, which may help stop swelling before it starts. Lymphovenous bypass is a surgical procedure that has been used to treat lymphedema by creating a new pathway for lymphatic fluid to drain, potentially reducing swelling.
Who is the study for?
This trial is for adults over 18 with inflammatory or locally advanced non-inflammatory breast cancer, planning to have underarm lymph node surgery and radiation therapy. It's not for pregnant individuals, those unable to follow up for at least 18 months, patients on anticoagulants within a week of surgery, or with a BMI over 50.
What is being tested?
The study tests if the lymphovenous bypass procedure can prevent arm swelling (lymphedema) when done before underarm lymph node surgery in breast cancer patients. Lymphangiography and Indocyanine Green are used to help perform this preventive measure.
What are the potential side effects?
Potential side effects may include discomfort at the site of the procedure, risk of infection from surgery, possible allergic reactions to dyes like Indocyanine Green used during imaging, and general surgical risks such as bleeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of lymphedema
Volumetric diagnosis of lymphedema
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (LVB)Experimental Treatment3 Interventions
Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND.
Group II: Group II (no intervention)Active Control1 Intervention
Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lymphangiography
2018
N/A
~130
Indocyanine green
FDA approved
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The lymphovenous bypass procedure creates a new pathway for lymphatic fluid to flow away from the arms, helping to prevent or reduce lymphedema, a common complication after breast cancer treatment. This is crucial for improving the quality of life for breast cancer patients by reducing swelling and discomfort.
Other common treatments for breast cancer include surgery (removal of the tumor or breast tissue), radiation therapy (using high-energy rays to kill cancer cells), chemotherapy (using drugs to destroy cancer cells), and hormone therapy (blocking hormones that fuel certain types of breast cancer). Each of these treatments targets cancer cells in different ways, aiming to eliminate the disease and prevent recurrence.
Nursing management of patients with lymphedema associated with breast cancer therapy.Physical Therapy Intervention to Augment Outcomes Of Lymph Node Transfer Surgery for a Breast Cancer Survivor with Secondary Upper Extremity Lymphedema: A Case Report.Evidence-based practice in the management of lower limb lymphedema after gynecological cancer.
Nursing management of patients with lymphedema associated with breast cancer therapy.Physical Therapy Intervention to Augment Outcomes Of Lymph Node Transfer Surgery for a Breast Cancer Survivor with Secondary Upper Extremity Lymphedema: A Case Report.Evidence-based practice in the management of lower limb lymphedema after gynecological cancer.
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,051 Previous Clinical Trials
1,798,605 Total Patients Enrolled
148 Trials studying Breast Cancer
63,242 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,878 Previous Clinical Trials
41,012,797 Total Patients Enrolled
946 Trials studying Breast Cancer
1,544,013 Patients Enrolled for Breast Cancer
Mark SchaverienPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have inflammatory breast cancer, or non-inflammatory breast cancer that is being treated with ALND and radiation therapy.You are 18 years old or older.You have taken blood thinners within 7 days before surgery.You have a very high body mass index (BMI).
Research Study Groups:
This trial has the following groups:- Group 1: Group I (LVB)
- Group 2: Group II (no intervention)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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