Surgical Procedure for Breast Cancer

Overseen By Edward I. Chang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Hypersensitivity to ICG, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: Surgery day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new surgical approach called vascularized lymph node transfer to reduce the risk of arm swelling, known as lymphedema, in breast cancer patients undergoing breast reconstruction. Lymphedema commonly occurs after breast cancer treatments. The procedure involves moving healthy lymph nodes from one part of the body to replace those removed during cancer treatment. It targets patients who have undergone treatments like mastectomy, lymph node removal, or radiation and are planning breast reconstruction. As an unphased trial, this study allows patients to contribute to innovative surgical advancements that could enhance post-treatment quality of life.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this surgical procedure is safe for breast cancer patients?

Research has shown that transferring lymph nodes with blood vessels (VLNT) is generally safe when combined with breast reconstruction. Past studies have used this procedure to treat or prevent arm swelling (lymphedema) related to breast cancer. Reports suggest it can be performed safely alongside breast reconstruction without major issues.

One study examined the safety of the donor area for lymph nodes and found low risks, even when combined with breast reconstruction. This finding indicates that VLNT is usually well-tolerated, with few serious side effects. Overall, current evidence supports VLNT as a promising option for reducing arm swelling in patients undergoing breast reconstruction, with a good safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Vascularized lymph node transfer is unique because it offers a new method of addressing lymphedema, a common complication after breast cancer surgery. Unlike traditional treatments like compression garments or lymphatic drainage therapy, this surgical procedure involves transferring healthy lymph nodes to the affected area, potentially restoring natural lymphatic function. Researchers are excited about this technique because it could offer a more permanent solution to lymphedema, reducing the need for ongoing management and improving patients' quality of life.

What evidence suggests that vascularized lymph node transfer is effective for lowering the risk of lymphedema in breast cancer patients?

Research has shown that moving healthy lymph nodes to replace those removed during breast cancer treatment can significantly reduce arm swelling, known as lymphedema. In this trial, participants will undergo vascularized lymph node transfer during standard breast reconstructive surgery. A review of studies found that this procedure can improve the size difference between arms by about 40% in patients with swelling in one arm. Another study reported an average reduction in arm swelling of about 54.8% over four years. This approach may also lower the risk of developing lymphedema after breast reconstruction. Overall, these findings suggest that this procedure effectively manages and reduces lymphedema in breast cancer patients. ^{1 2 3 5 6}

Who Is on the Research Team?

Edward I. Chang

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for breast cancer patients who've had a mastectomy, lymph node removal, radiation, and chemotherapy and are now planning breast reconstruction. It's not for those pregnant or allergic to specific dyes used during surgery.

Inclusion Criteria

I have completed treatment for breast cancer and am seeking breast reconstruction.

Exclusion Criteria

Patients that are known to be pregnant at the time of surgery

You are allergic to indocyanine green (ICG) or isosulfan blue (Lymphazurin).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery

Surgery day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Follow-up at 3 weeks, 3 months, 6 months, 1 year, and 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Vascularized Lymph Node Transfer

Trial Overview The study tests a new surgical method called vascularized lymph node transfer alongside breast reconstruction to see if it can reduce the risk of developing arm swelling (lymphedema) after surgery.

How Is the Trial Designed?

Group I: Treatment (vascularized lymph node transfer) Experimental Treatment 2 Interventions

Patients undergo vascularized lymph node transfer during standard of care breast reconstructive surgery.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Intra-abdominal vascularized lymph node transfer (VLNT) is an effective treatment for lymphedema, showing a mean reduction in limb circumference or volume of up to 70.8% across 21 studies involving 594 patients.

The procedure has a low complication rate, with only 1.4% for donor-site complications and 3.2% for recipient-site complications, indicating it is a safe option that does not impair lymph function at the donor site.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-abdominal vascularized lymph node transfer for treatment of lymphedema: A systematic literature review and meta-analysis. Li, Y., Dong, R., Li, Z., et al.[2021]

Vascularized lymph node transfer from the greater curvature of the stomach (VLNTg) is a promising surgical option for treating upper extremity lymphedema in breast cancer patients, with a review of 24 cases showing no complications and easily concealable scars.

Most patients (18 out of 24) had experienced lymphedema for over a year, yet VLNTg still resulted in significant improvements, indicating its efficacy even in long-standing cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascularized gastroepiploic lymph node transfer significantly improves breast cancer-related lymphedema. Mousavi, SR., Akbari, ME., Zarrintan, S.[2020]

The study identified an average of 5.2 lymph nodes in the level I neck region from 73 patients, providing essential anatomical data that can help optimize vascularized lymph node transfer (VLNT) surgeries for lymphedema treatment.

Current literature supports that level I neck lymph nodes are a reliable source for free lymph node transfer, making VLNT an effective surgical option for managing lymphedema while minimizing donor-site complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantification of level I neck lymph nodes for lymph node transfer in lymphedema treatment: an anatomical study and review of literature. Rozen, WM., Niumsawatt, V., Gibson, LD., et al.[2023]

In a study of 100 patients undergoing supraclavicular vascularized lymph node transfer (VLNT) for lymphedema, there were no cases of flap loss, indicating a high level of surgical success and safety.

The procedure demonstrated low morbidity, with only 3% of flaps requiring re-exploration for venous congestion and a few cases of local infection and chyle leak that resolved spontaneously, making it a promising option for lymphedema treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of supraclavicular free flap with vascularized lymph node transfer for treatment of lymphedema: A prospective study of 100 consecutive cases. Maldonado, AA., Chen, R., Chang, DW.[2022]

Vascularized lymph node transfer (VLNT) can significantly reduce the volume difference between affected and healthy arms in patients with breast cancer-related lymphedema by approximately 40%.

VLNT is associated with improved quality of life, a decrease in skin infection rates, and a notable number of patients (27 out of 60) being able to stop using compression garments, all while maintaining a low complication rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of vascularized lymph node transfer for breast cancer-related lymphedema. Winters, H., Tielemans, HJP., Paulus, V., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11900231/

Simultaneous Vascularized Lymph Node Transfer and ... A total of 168 complications (21.8%) were reported, with donor site seromas being the most common. Additionally, four partial and three total ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2213333X21004339

A systematic review and meta-analysis of vascularized ... The current evidence indicates that VLNT can improve the volume differences between the arms in patients with unilateral lymphedema by ∼40%.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03990610

Study Details | NCT03990610 | An Investigational Surgical ... This trial studies how an investigational surgical procedure called vascularized lymph node transfer works in lowering the risk of arm swelling (lymphedema) in ...

4. abs.amegroups.org abs.amegroups.org/article/view/7019/html

A comprehensive treatment algorithm for patients requiring ... A mean volume reduction of 54.8% between upper limbs was documented (52.9% for Stage 1, 54.3% for Stage 2, and 61% for Stage 3 lymphedema) at the mean 4 years ...

5. mdpi.com mdpi.com/2077-0383/14/20/7281

Proximal vs. Recipient Site for Vascular Lymph Node ... 5. Conclusions. Vascularized lymph node transfer is an effective surgical intervention for patients with BCRL, offering improvements in limb volume, frequency ...

6. jprasurg.com jprasurg.com/article/S1748-6815(24)00519-9/fulltext

Donor-site safety in microvascular lymph node transfer for ... This study explored the risks associated with donor-site morbidity following groin VLNT, with or without concomitant breast reconstruction.