Five-year, multi-site trial to assess lymphedema prevention concludesJun. 20, 2022, 10:01 AM
by Nancy Wise
Vanderbilt University School of Nursing Professor Sheila Ridner, PhD, recently completed a large randomized trial to assess early detection methods coupled with a prevention intervention for lymphedema, a common side effect of breast-cancer treatments.
Lymphedema, a chronic condition that causes fluid buildup in the body, can be caused by damage from cancer treatment for breast and other cancers such as cancer of the head and neck. The resulting swelling can complicate patients’ mobility and even result in death in extreme circumstances, such as with airway compromise or cellulitis that is unresponsive over time to antibiotics.
The study Ridner designed and led compared the effectiveness of using bioimpedance spectroscopy (BIS) measuring technology with traditional tape measurements in early identification of lymphedema swelling and immediate short-term hand and arm compression therapy. BIS, a painless and noninvasive procedure that works by passing a low-level electrical current through the body, uses non-invasive technology similar to that used by electronic monitors for body mass index. BIS is able to detect changes in extracellular fluid, while tape measurement can only detect change in the volume of the entire arm.
Patients were assigned to a BIS or tape measurement group at 10 sites around the world. Those in the BIS group were assessed using an L-Dex U400 from ImpediMed Limited. The trial found that patients with early detection who used L-Dex with additional intervention were less likely to progress to chronic lymphedema than patients monitored with a tape measure receiving the same intervention.
The statistically significant results were published in Lymphatic Research and Biology earlier this year. In their paper, Ridner and her co-authors concluded that BIS screening should be “a standard approach for prospective breast cancer-related lymphedema surveillance.”
Currently, 5% to 40% of women who undergo breast cancer surgery will likely experience some level of lymphedema, according to Breastcancer.org, and that risk is higher in women who undergo axillary lymph node dissections, chemotherapy or radiation.
Earlier detection of lymphedema “gives clinicians the information they need to begin early intervention on their patients at a stage when it’s possible to keep the lymphedema from advancing,” Ridner said. “These findings provide all clinicians addressing lymphedema in breast cancer patients with clear scientific data regarding the optimal measurement and sound evidence to switch from using tape measurements.”
“This is a victory for patients, particularly the 1,200 breast cancer patients who volunteered for this study. I thank them and all the collaborators at 13 hospitals across the U.S. and Australia for their dedicated work over several years,” she added.
Prior to joining Vanderbilt University School of Nursing, Ridner was an oncology and psychiatric-mental health nurse who saw the debilitating issues lymphedema caused patients. Then her mother developed lymphedema. Ridner since has dedicated much of her research to increasing quality of life for patients dealing with the painful condition. She has worked on alleviating lymphedema in various ways, from studying yoga as a form of therapy to working on a potential head and neck device to alleviate patients’ pain. Ridner has been continuously funded as a nurse scientist since receiving pre-doctoral funding in 2001. She has received more than $10 million in funding for treatment research since 2001. In 2017, she was named to the International Nurse Researcher Hall of Fame.
“My mother was diagnosed with breast cancer and developed the condition,” said Ridner. “It got to the point where she couldn’t even play her favorite instrument, the piano. If we could have caught it earlier, it may not have progressed as it did for her.”
In addition to Ridner, the lead research team included co-investigators Mary Dietrich, PhD, from Vanderbilt University Schools of Nursing and Medicine; Chirag Shah, MD, Cleveland Clinic; and Frank Vicini, MD, 21st Century Oncology (now GenesisCare).
Sites participating in the study were Allegheny General Hospital, Pittsburgh, Pennsylvania; Columbia Medical Center, New York, New York; Macquarie University, Australia; Massey Cancer Center, Virginia Commonwealth University Health Systems, Richmond, Virginia; Mayo Clinic, Jacksonville, Florida; Southeast Health Southeast Cancer Center, Cape Girardeau, Missouri; University of Kansas Medical Center, Westwood, Kansas; University of Louisville/Department of Surgery/Division of Surgical Oncology, Louisville, Kentucky; University of Texas MD Anderson Cancer Center, Houston, Texas; and Vanderbilt University School of Nursing, Nashville, Tennessee.
The study was funded by ImpediMed, medi, and by the National Institutes of Health (NIH/NCATS UL1 TR000445).