CompletedPhase 1

Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development

United States80 participantsStarted 2017-04-24

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Lymphatic propulsive velocity as assessed by NIRFLI

Timeframe: immediately before surgery

Lymphatic propulsive velocity as assessed by NIRFLI

Timeframe: immediately before radiation (which is 6-8 weeks after surgery)

Lymphatic propulsive velocity as assessed by NIRFLI

Timeframe: 6 months after radiation

Lymphatic propulsive velocity as assessed by NIRFLI

Timeframe: 12 months after radiation

Lymphatic propulsive velocity as assessed by NIRFLI

Timeframe: 24 months after radiation

Lymphatic propulsive frequency as assessed by NIRFLI

Timeframe: immediately before surgery

Lymphatic propulsive frequency as assessed by NIRFLI

Timeframe: immediately before radiation (which is 6-8 weeks after surgery)

Trial details

NCT IDNCT02949726

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-01

View on ClinicalTrials.gov More Lymphedema trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Lymphatic propulsive velocity as assessed by NIRFLI

Timeframe: immediately before surgery

Lymphatic propulsive velocity as assessed by NIRFLI

Timeframe: immediately before radiation (which is 6-8 weeks after surgery)

Lymphatic propulsive velocity as assessed by NIRFLI

Timeframe: 6 months after radiation

Lymphatic propulsive velocity as assessed by NIRFLI

Timeframe: 12 months after radiation

Lymphatic propulsive velocity as assessed by NIRFLI

Timeframe: 24 months after radiation

Lymphatic propulsive frequency as assessed by NIRFLI

Timeframe: immediately before surgery

Lymphatic propulsive frequency as assessed by NIRFLI

Timeframe: immediately before radiation (which is 6-8 weeks after surgery)