What side effects are associated with this type of intervention?

Common treatments for breast cancer, including lumpectomy, radiotherapy, chemotherapy, anti-Her2 therapy, and antihormonal therapy, are associated with several side effects. These can include weakness and fatigue, insomnia, chemotherapy-induced peripheral neuropathy (CIPN), lymphedema, and drug-induced arthralgia. Specifically, radiotherapy and surgical interventions like lymphovenous bypass, which aim to prevent or treat lymphedema, can lead to arm swelling, discomfort, and restricted range of motion. While lymphovenous bypass has shown promise in reducing lymphedema symptoms, it is generally associated with modest improvements in limb volume and symptom relief.

What prior FDA approvals exist?

FDA-approved treatments for breast cancer include various chemotherapeutic agents, hormone therapies, and targeted therapies. For instance, liposomal doxorubicin (L-DOX) is noted for its anticancer and cardioprotective effects in breast cancer treatment. Additionally, trastuzumab-containing regimens are used for early breast cancer, although they carry risks of cardiotoxicity. While the Lymphovenous Bypass procedure itself is not an FDA-approved treatment but rather a surgical intervention to prevent lymphedema, it is part of ongoing research to improve outcomes for breast cancer patients. Other treatments like advanced pneumatic compression devices (APCD) have shown benefits in reducing lymphedema-related complications.

What other types of research exist?

Promising novel alternatives to Lymphovenous Bypass for breast cancer patients include: 1) Minimally invasive multiple lymphaticovenular anastomosis (LVA) at the ankle, which has shown preliminary success in preventing lower leg lymphedema and could be adapted for upper limbs. 2) Modified lambda-shaped LVA, which has demonstrated effectiveness in reducing edematous volume in cancer-related lymphedema. These techniques offer potential benefits in managing lymphatic fluid and preventing lymphedema.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

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

Do I qualify?Apply below to find out

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.