Allegheny Health Network Clinical Trial Examines New Modality for Early Detection of Lymphedema, a Chronic Side Effect of Breast Cancer Treatment

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The clinical trial at Pittsburgh-based Allegheny Health Network looks at whether bioimpedance spectroscopy can detect lymphedema at its earliest stages, when it could be prevented.

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"In order to decrease the number of women suffering from lymphedema, we must improve our methods of early diagnosis." Michael Cowher, MD, breast surgeon, Allegheny Health Network

Allegheny Health Network (AHN) researchers are investigating whether lymphedema, one of the most common complications of breast cancer treatment, can be prevented or lessened in severity by using bioimpedance spectroscopy to detect the condition early, before it has caused any symptoms.

More than 300,000 women are diagnosed annually with breast cancer in the U.S., and the number of long-term survivors is growing. Depending on the treatment used, anywhere from five to 50 percent of breast cancer patients will develop lymphedema, excess fluid which accumulates in the arm. Lymphedema can become a chronic condition marked by pain, numbness, loss of limb function and subsequent decline in quality of life.

“Diagnosing lymphedema poses a significant challenge, as traditional methods can be unreliable, costly, and unable to detect small accumulations of fluid, which can happen before the patient experiences symptoms,” said AHN physician Michael Cowher, MD, Quality Assurance Director, Breast Surgical Oncology and principal investigator of the study. “We believe that bioimpedance spectroscopy, a non-invasive and highly sensitive technology may be able to detect lymphedema before it is visible to the doctor or patient.”

The study seeks to evaluate if bioimpedence measurement detects this ‘subclinical’ lymphedema more accurately than traditional measurements. In addition, if patients in the study show signs of developing subclinical lymphedema, they will be provided with compression garments to attempt to prevent lymphedema progression.

Lymphedema is a progressive disease that begins as undetectable swelling, and in its most severe form can resemble elephantiasis. Traditionally women are diagnosed only after they exhibit clinically observable fluid accumulation. Techniques for measuring arm circumference – tape measuring, infrared light, water displacement and patient self-assessment – do not reliably detect earliest-stage lymphedema.

AHN is the only health care provider in the Pittsburgh area offering women access to the bioimpedance spectroscopy trial, joining other leading national institutions such as the Mayo Clinic, Vanderbilt University and MD Anderson Cancer Center.

“In order to decrease the number of women suffering from chronic lymphedema, we must improve our methods of early diagnosis,” Dr. Cowher said. “Bioimpedance spectroscopy has been used successfully in laboratory and clinical settings to detect low levels of fluid accumulation. Measurements are made through electrodes attached to the patient’s skin and the current is not felt by the patient – it is very similar to having an EKG.”

Bioimpedance spectroscopy measures how easily a small electrical current flows through the body, detecting water volume, and lean and fat tissue. In addition to measuring lymphedema, it is also used in measuring lean body mass.

“This study will explore the possibility that routine evaluation of at-risk limbs with bioimpedance spectroscopy can afford breast cancer patients the opportunity to prevent chronic lymphedema and decreased quality of life associated with the condition,” Dr. Cowher said. “It will also examine whether early treatment can slow progression of the disease, or shorten the treatment time needed, and assess factors that may contribute to the development of lymphedema, such as obesity, smoking or air travel.”

Through their work with the National Surgical Adjuvant Breast and Bowel Project (NSABP), AHN physicians have contributed to significant protocol and practice changes in the treatment of breast cancer, including breast conservation through lumpectomy rather than radical mastectomy. The Cancer Institute’s radiation oncologists offer the latest treatments including partial breast irradiation, shorter courses of radiation, brachytherapy, and Intensity-Modulated Radiation Therapy (IMRT), and are currently developing new programs that will advance breast cancer treatment and convenience for patients. AHN also offers 3-D mammography, one of the most advanced techniques for detecting breast cancer at its earliest, most curable stages, at 10 sites throughout the region.

“AHN has long been known for pioneering approaches to treatment that have set new standards for high quality cancer care,” said David Parda, MD, Chair, AHN Cancer Institute. “We are proud to offer this clinical trial exploring a new modality that could lessen the long-term impact of lymphedema on breast cancer survivors and improve their quality of life.”

Through a collaboration with the Johns Hopkins Kimmel Cancer Center, one of the country’s most respected cancer care centers designated by the National Cancer Institute, AHN’s doctors can directly share their most up to date research findings, and in turn provide patients with the most effective treatments.

The bioimpedance spectroscopy trial is open to women diagnosed with Stage I-III invasive breast cancer or Ductal Carcinoma in Situ (DCIS) who are undergoing one of the following: mastectomy, axillary dissection, sentinel node biopsy, radiation therapy or taxane-based chemotherapy. They will be randomly assigned to have arm measurements either by tape measure or by bioimpedance spectroscopy.

For more information on trial enrollment, contact Samantha Cavolo at 412.359.6449. More information on some of the clinical trials available through the AHN Cancer Institute is available at https://www.ahn.org/cancer-institute/clinical-trials-and-research

About Allegheny Health Network Cancer Institute
Allegheny Health Network’s (AHN) Cancer Institute offers a complete spectrum of oncology care, including access to state-of-the-art technologies and new therapies being explored in clinical cancer trials. The Network’s radiation oncology program is the largest in the country and accredited by the American College of Radiology. AHN also has a formal affiliation with the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, one of the nation’s 41 comprehensive cancer centers designated by the National Cancer Institute, for research, medical education and clinical services.

To schedule an appointment with an AHN oncologist, please call 412.DOCTORS or visit http://www.ahn.org/find-a-doctor.

For more information about how to schedule a breast tomosynthesis appointment at AHN, call 412-DOCTORS (362-8677).

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Stephanie Waite