SAN DIEGO, July 21 /PRNewswire/ -- Bioimpedance spectroscopy (BIS) is more accurate and reliable than other methods of subclinical assessment of lymphedema in breast cancer patients, according to a paper published in the July 20 issue of Journal of Clinical Oncology (2008; Vol. 26, Issue 21: 3536- 3542).
Titled "Lymphedema After Breast Cancer: Incidence, Risk Factors, and Effect on Upper Body Function," the paper, authored by Sandra Hayes, PhD., and colleagues from Queensland University of Technology in Australia, is based on a study that involved 265 breast cancer patients. Approximately 87 percent of the patients had undergone lymph node dissection, 70 percent had received radiation therapy and 40 percent had received chemotherapy and/or hormone treatment. The study's investigators conducted assessments of the patients for the evidence of lymphedema at three monthly intervals between six- and 18-months post-surgery using a BIS device, sum of arm circumference (SOAC) and patients' self-reporting.
Using BIS, the investigators were able to detect 60 percent of the lymphedema cases that were missed when assessments were conducted with the SOAC method and 40 percent that were missed through self-reporting. For women treated on their non-dominant side, the SOAC method exhibited even lower sensitivity, with approximately eight out of every 10 patients with subclinical lymphedema going undetected. The self-reporting method showed low specificity, with a 40 percent false positive rate (40 percent of patients who did not have lymphedema were reported as having the condition).
"Early intervention is critical to the management and treatment of lymphedema, and these latest findings further support the use of bioimpedance spectroscopy as a direct, accurate and reliable measure to aid doctors with the clinical assessment of the condition," said Greg Brown, CEO of ImpediMed, which has the only FDA cleared device for the clinical assessment by health care providers of secondary lymphedema of the arm in women.
Lymphedema is a condition that can cause significant swelling of the upper and lower extremities due to the build-up of excess lymph fluid. This can occur when the lymphatic system, which is responsible for draining excess fluid from the body and is a key component of the immune system, is damaged or altered. In breast cancer patients, this can occur after surgery, such as removal or biopsy of the lymph nodes, and/or radiation therapy. It is estimated that 6 percent to 40 percent of patients with breast cancer develop lymphedema, and that it often occurs within the first two years after surgery. For some cancer survivors and others at risk, a low level lymphedema can occur 10 years to 15 years following the initial primary treatment and develop into a condition that has a serious impact on overall health and quality of life. For more information about lymphedema, visit http://www.nci.nih.gov/cancerinfo/pdq/supportivecare/lymphedema/patient/.
ImpediMed is the world leader in the development and distribution of medical devices employing Bioimpedance Spectroscopy (BIS) technologies for use in the non-invasive clinical assessment and monitoring of human disorders and diseases. ImpediMed's primary product range consists of a number of medical devices that enable surgeons, oncologists, therapists and radiation oncologists to clinically assess patients early for the potential onset of secondary lymphedema. Pre-operative clinical assessment in breast cancer survivors, before the onset of symptoms, may prevent the condition from becoming a lifelong management issue and thus improve the quality of life of the cancer survivor. ImpediMed has the only medical device with FDA clearance in the United States for the clinical assessment, by health care providers, of secondary lymphedema of the arm in women. For more information, visit http://www.impedimed.com.
Note: ImpediMed's device is not intended to diagnose or predict
lymphedema of an extremity.
Contacts: Wendy Lau or David Schull
Russo Partners LLC
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