Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development



Status:Recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/17/2018
Start Date:April 24, 2017
End Date:April 2021
Contact:Melissa B Aldrich, PhD
Email:Melissa.B.Aldrich@uth.tmc.edu
Phone:713-248-2642

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The goal of this study is to find out which immune molecules, cells, and genes are involved
in the development of lymphedema (LE), so that medicines that target them can be considered
for treating lymphedema. The hypothesis is that LE is a systemic, autoimmune-like disease
that is initiated by inflammatory cytokines induced by surgery, radiation, and possibly
chemotherapy in genetically susceptible patients.


Inclusion Criteria:

- Participants must be at least 18 years of age

- Participants must have been clinically diagnosed with breast cancer and scheduled for
axillary lymph node dissection (ALND) and radiation treatment at MD Anderson
(receiving chemotherapy, mastectomy or breast-conserving surgery, ALND (>10 nodes) and
radiation treatment for breast cancer, identified by Drs. Mittendorf and Shaitelman of
the Nellie B. Connally Breast Cancer Center at MD Anderson)

- Ambulatory and possessing all four limbs

- No prior radiation therapy

- Negative urine pregnancy test within 36 hours prior to study drug administration, if
of childbearing potential

- Females participants must complete the Female Enrollment Form. Childbearing potential
participants must agree to use one of the medically accepted forms of contraception
for a period of one month after study participation. Female participants who meet the
criteria for non-childbearing will still complete the Female Enrollment Form, but are
not restricted to the use of contraception following study participation.

Exclusion Criteria:

- Participants with a known or suspected allergy to iodine

- Participants who are breastfeeding, pregnant or trying to become pregnant

- Severe underlying chronic illness or disease (other than breast cancer)

- Participants not capable of keeping moderately still for the imaging portion of the
study session (~1 hour for imaging)
We found this trial at
1
site
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Phone: 713-248-2642
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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mi
from
Houston, TX
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