Clinical trial NCT02949726: Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development
Official title: Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lymphedema
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
name: National Cancer Institute (NCI)
First posted: 2016-10-31
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Lymphatic propulsive velocity as assessed by NIRFLI
timeFrame: immediately before surgery
measure: Lymphatic propulsive velocity as assessed by NIRFLI
timeFrame: immediately before radiation (which is 6-8 weeks after surgery)
measure: Lymphatic propulsive velocity as assessed by NIRFLI
timeFrame: 6 months after radiation
measure: Lymphatic propulsive velocity as assessed by NIRFLI
timeFrame: 12 months after radiation
measure: Lymphatic propulsive velocity as assessed by NIRFLI
timeFrame: 24 months after radiation
measure: Lymphatic propulsive frequency as assessed by NIRFLI
timeFrame: immediately before surgery
measure: Lymphatic propulsive frequency as assessed by NIRFLI
timeFrame: immediately before radiation (which is 6-8 weeks after surgery)
measure: Lymphatic propulsive frequency as assessed by NIRFLI
timeFrame: 6 months after radiation
measure: Lymphatic propulsive frequency as assessed by NIRFLI
timeFrame: 12 months after radiation
measure: Lymphatic propulsive frequency as assessed by NIRFLI
timeFrame: 24 months after radiation
measure: Percent extravascular dye as assessed by NIRFLI
timeFrame: immediately before surgery
measure: Percent extravascular dye as assessed by NIRFLI
timeFrame: immediately before radiation (which is 6-8 weeks after surgery)
measure: Percent extravascular dye as assessed by NIRFLI
timeFrame: 6 months after radiation
measure: Percent extravascular dye as assessed by NIRFLI
timeFrame: 12 months after radiation
measure: Percent extravascular dye as assessed by NIRFLI
timeFrame: 24 months after radiation
measure: Vessel tortuosity as assessed by NIRFLI
timeFrame: immediately before surgery
measure: Vessel tortuosity as assessed by NIRFLI
timeFrame: immediately before radiation (which is 6-8 weeks after surgery)
measure: Vessel tortuosity as assessed by NIRFLI
timeFrame: 6 months after radiation
measure: Vessel tortuosity as assessed by NIRFLI
timeFrame: 12 months after radiation
measure: Vessel tortuosity as assessed by NIRFLI
timeFrame: 24 months after radiation
measure: Vessel dilation ratio as assessed by NIRFLI
timeFrame: immediately before surgery
measure: Vessel dilation ratio as assessed by NIRFLI
timeFrame: immediately before radiation (which is 6-8 weeks after surgery)
measure: Vessel dilation ratio as assessed by NIRFLI
timeFrame: 6 months after radiation
measure: Vessel dilation ratio as assessed by NIRFLI
timeFrame: 12 months after radiation
measure: Vessel dilation ratio as assessed by NIRFLI
timeFrame: 24 months after radiation
Secondary outcomes:
measure: Chemokine levels as assessed by bead assay
timeFrame: immediately before surgery
measure: Chemokine levels as assessed by bead assay
timeFrame: immediately before radiation (which is 6-8 weeks after surgery)
measure: Chemokine levels as assessed by bead assay
timeFrame: 6 months after radiation
measure: Chemokine levels as assessed by bead assay
timeFrame: 12 months after radiation
measure: Chemokine levels as assessed by bead assay
timeFrame: 24 months after radiation
measure: Cytokine levels as assessed by bead assay
timeFrame: immediately before surgery
measure: Cytokine levels as assessed by bead assay
timeFrame: immediately before radiation (which is 6-8 weeks after surgery)
measure: Cytokine levels as assessed by bead assay
timeFrame: 6 months after radiation
measure: Cytokine levels as assessed by bead assay
timeFrame: 12 months after radiation
measure: Cytokine levels as assessed by bead assay
timeFrame: 24 months after radiation
measure: Number of participants with autoimmune antibodies as assessed by ELISA
timeFrame: immediately before surgery
measure: Number of participants with autoimmune antibodies as assessed by ELISA
timeFrame: immediately before radiation (which is 6-8 weeks after surgery)
measure: Number of participants with autoimmune antibodies as assessed by ELISA
timeFrame: 6 months after radiation
measure: Number of participants with autoimmune antibodies as assessed by ELISA
timeFrame: 12 months after radiation
measure: Number of participants with autoimmune antibodies as assessed by ELISA
timeFrame: 24 months after radiation
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Melissa B Aldrich, PhD
role: PRINCIPAL_INVESTIGATOR
References: