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

25 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how an investigational surgical procedure called vascularized lymph node transfer works in lowering the risk of arm swelling (lymphedema) in patients with breast cancer undergoing breast reconstruction. Patients who undergo breast reconstruction are often at high risk of developing lymphedema. Vascularized lymph node transfer involves transferring lymph nodes from an unaffected area of the body to replace those removed as part of treatment, which may lower the risk of lymphedema after breast reconstruction.

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 data supports the effectiveness of the treatment Vascularized Lymph Node Transfer for breast cancer-related lymphedema?

Research shows that Vascularized Lymph Node Transfer (VLNT) is a promising surgical treatment for reducing lymphedema (swelling due to fluid build-up) after breast cancer therapy. Studies indicate that VLNT can improve the quality of life and reduce swelling in the affected area, although results can vary. ^{1 2 3 4 5}

Is vascularized lymph node transfer generally safe for humans?

Vascularized lymph node transfer is generally considered safe, but there are potential complications, such as a high-output chyle leak (a fluid leak from the lymphatic system) at the donor site, which can be dangerous if not managed properly. Surgeons performing this procedure should be aware of these risks and know how to address them. ^{2 6 7 8 9}

How is the treatment Vascularized Lymph Node Transfer different from other treatments for breast cancer-related lymphedema?

Vascularized Lymph Node Transfer (VLNT) is unique because it involves surgically transferring healthy lymph nodes to areas affected by lymphedema (swelling due to lymph fluid buildup), which can occur after breast cancer treatment. This method is different from other treatments as it directly addresses the lymphatic system by restoring its function, rather than just managing symptoms. ^{3 5 8 10 11}

Research Team

Edward I. Chang

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Influence of vascularized lymph node transfer (VLNT) flap positioning on the response to breast cancer-related lymphedema treatment. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Critical Ischemia Time, Perfusion, and Drainage Function of Vascularized Lymph Nodes. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Clinical and Psychosocial Outcomes of Vascularized Lymph Node Transfer for the Treatment of Upper Extremity Lymphedema After Breast Cancer Therapy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of vascularized lymph node transfer for breast cancer-related lymphedema. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The surgical anatomy of the supraclavicular lymph node flap: A basis for the free vascularized lymph node transfer. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Management of High-Output Chyle Leak after Harvesting of Vascularized Supraclavicular Lymph Nodes. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Intratissue lymphovenous communications in the mechanism of action of vascularized lymph node transfer. [2022]

8. United States 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Intra-abdominal vascularized lymph node transfer for treatment of lymphedema: A systematic literature review and meta-analysis. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Vascularized gastroepiploic lymph node transfer significantly improves breast cancer-related lymphedema. [2020]

11. China (Republic : 1949- ) 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. [2023]