Inflammatory Response and Tissue Fibrosis/ Lymphatico-venous Bypass

Completed

Conditions studied: Breast Cancer, Genitourinary Cancer, Malignant Female Reproductive System Neoplasm, Melanoma, Sarcoma

In brief

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.

Key facts

Study ID

NCT01433302

Run by

M.D. Anderson Cancer Center

People needed

21

Starts

2012-03-01

Expected to finish

2014-03-01

Last updated by the study team

2015-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients undergoing lymphatico-venular bypass for lymphedema.
• History of axillary lymph node dissection, sentinel lymph node biopsy or dissection.
• A minimum of three (3) months post-op from any surgical interventions.
• A minimum of six (6) months from the last dose of chemotherapy.
• Patients with unilateral lymphedema.

You may not qualify if…

• Active systemic infection or allergic reaction.
• Active parasitic infection.
• History of primary (congenital) lymphedema.
• Metastatic cancer.
• History of autoimmune disorders including lupus, rheumatoid arthritis, vasculitis, systemic sclerosis.
• History of other fibroproliferative disorders including cirrhosis, pulmonary fibrosis, kidney fibrosis, systemic sclerosis, scleroderma.
• Current treatment with steroids.
• Concurrent secondary systemic cancer exclusive of cutaneous malignancies.
• Treatment with myelosuppressive or stimulatory drugs within six (6) months of enrollment.
• History of bone marrow transplantation.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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