Clinical trial NCT01433302: Inflammatory Response and Tissue Fibrosis/ Lymphatico-venous Bypass
Official title: Determination of the Effect of Lymphatico-venous Bypass Surgery on Inflammatory Responses and Tissue Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Genitourinary Cancer
Malignant Female Reproductive System Neoplasm
Melanoma
Sarcoma
Keywords: Breast cancer
Genitourinary cancer
Gynecological cancer
Malignant Female Reproductive System Neoplasm
Melanoma
Sarcoma
Inflammatory Response
Inflammatory proteins
Tissue Fibrosis
Lymphatico-venous Bypass Surgery
Punch biopsy
Lab collections
Th2 immune phenotype
Lymphedema
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2011-09-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: UT MD Anderson Cancer Center patients, 18 years of age or older, undergoing lymphatico-venular bypass for stage II or greater lymphedema.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Th2 Cytokine Levels
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: David W. Chang, MD
role: PRINCIPAL_INVESTIGATOR
References: