Inflammatory Response and Tissue Fibrosis/ Lymphatico-venous Bypass

Breast Cancer Clinical Trial

Official title:

Determination of the Effect of Lymphatico-venous Bypass Surgery on Inflammatory Responses and Tissue Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433302
• Other study ID #: 2011-0455
• Secondary ID: BC103691
• Status: Completed
• Phase: N/A
• First received: September 8, 2011
• Last updated: May 5, 2015
• Start date: March 2012
• Est. completion date: March 2014

Study information

• Verified date: May 2015
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The goal of this clinical research study is to measure the amount of inflammatory proteins inside the body before and after lymphatico-venular bypass surgery. This will help doctors learn if anti-fibrotic or anti-inflammatory drugs/treatments given with the surgery can improve how well the surgery works.

Description:

If you choose to take part in this study, you will have 1 small piece of tissue (about the size of a pencil eraser) collected from the arm with the lymphedema and another small piece of tissue will be collected from the unaffected arm. A total of 4 samples will be collected by excisional biopsy (2 samples before the surgery and 2 more samples again 6 months after the surgery). To collect an excisional biopsy, the area of skin is numbed with anesthetic and a small cut is made to remove all or part of the affected tissue.

Blood (about 5 teaspoons each time) will also be drawn before the surgery and 1 more blood sample again 6 months after the surgery. If possible, the blood samples will be collected during already scheduled blood draws to avoid additional needle sticks.

The tissue and blood samples will be used for testing to evaluate the level of the tissue inflammation and to check for any build-up of excess tissue.

Length of Study:

After both tissue and blood samples have been collected, your participation in this study will be over.

This is an investigational study.

Up to 30 patients will take part in this study. All will be enrolled at MD Anderson.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients undergoing lymphatico-venular bypass for lymphedema.

2. History of axillary lymph node dissection, sentinel lymph node biopsy or dissection.

3. A minimum of three (3) months post-op from any surgical interventions.

4. A minimum of six (6) months from the last dose of chemotherapy.

5. Patients with unilateral lymphedema.

Exclusion Criteria:

1. Active systemic infection or allergic reaction.

2. Active parasitic infection.

3. History of primary (congenital) lymphedema.

4. Metastatic cancer.

5. History of autoimmune disorders including lupus, rheumatoid arthritis, vasculitis, systemic sclerosis.

6. History of other fibroproliferative disorders including cirrhosis, pulmonary fibrosis, kidney fibrosis, systemic sclerosis, scleroderma.

7. Current treatment with steroids.

8. Concurrent secondary systemic cancer exclusive of cutaneous malignancies.

9. Treatment with myelosuppressive or stimulatory drugs within six (6) months of enrollment.

10. History of bone marrow transplantation.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Genital Neoplasms, Female
• Genitourinary Cancer
• Malignant Female Reproductive System Neoplasm
• Melanoma
• Sarcoma
• Urogenital Neoplasms

Intervention

Procedure:
• Punch Biopsy
5 mm punch biopsy specimens from the affected, lymphedematous limb will be obtained just prior to lymphatico-venular bypass and six (6) months after lymphatico-venular bypass. Punch biopsies will be obtained from the radial (lateral) aspect of the upper arm approximately 10cm above the olecranon process. Biopsy specimens will be collected from the contralateral (normal) arm at the exact same location.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Th2 Cytokine Levels	5 mm punch biopsy specimens from the affected, lymphedematous limb will be obtained just prior to lymphatico-venular bypass and six (6) months after lymphatico-venular bypass. Punch biopsies will be obtained from the radial (lateral) aspect of the upper arm approximately 10cm above the olecranon process. Biopsy specimens will be collected from the contralateral (normal) arm at the exact same location.	6 months	No

External Links

•   University of Texas MD Anderson Cancer Center Website