Sponsored By: National Cancer Institute
If you have been recently diagnosed with stage I-III breast cancer and are planning to undergo axillary lymph node dissection, you may be eligible to participate in a trial studying the prevention of lymphedema through education, counseling and exercise.
The multi-center trial will compare the incidence and severity of lymphedema in women who receive education about lymphedema versus women who receive education and participate in an exercise program.
Background of the Lymphedema Study
Lymphedema is a condition in which excess lymph fluid collects in tissue and causes swelling. Lymph fluid, which travels through our bodies removing waste products and helping to fight infection, may accumulate in the arm after surgery.
Lymphedema affects an estimated 7 percent to over 50 percent of women affected by breast cancer, depending on the type of treatment. Previous studies have suggested that women who have surgery to remove lymph nodes in the underarm are at risk. Radiation to this area also increases lymphedema risk.
To determine the extent of breast cancer, most women undergo sampling of axillary lymph nodes, a procedure in which a doctor removes lymph nodes from the armpit so they can be checked for the presence of cancer. The axillary lymph node is a common site of metastases of breast cancer cells because it drains lymph channels from the breast.
When axillary nodes are absent, lymph fluid may accumulate in the arm, thereby creating a greater risk for developing lymphedema.
The first area breast cancer cells may travel is the sentinel lymph nodes, the lymph nodes in the armpit that filter fluid moving away from the breast. Sentinel node biopsy, a procedure that involves removing only the sentinel nodes to check for the presence of cancer, can eliminate the need for an axillary node dissection and lower the risk of developing lymphedema.
Lymphedema can be debilitating, and it is a frightening prospect or reality for many women. This study is important because it will investigate ways to prevent or lessen the effects of lymphedema.
Design of the Lymphedema Study
The study will be conducted at treatment centers throughout the United States. Before surgery, women in all treatment centers will complete a questionnaire to assess their knowledge of lymphedema, arm range of motion, arm circumference (the distance around the arm), information about their lifestyle (demographics), their quality of life around health issues, and how they feel about cancer recurrence, their ability to learn new tasks (called self-efficacy) and body image. Then the women will undergo breast surgery and axillary lymph node sampling as a part of routine clinical care. They may or may not undergo sentinel lymph node sampling.
Depending on the location of the treatment center, women will be randomly assigned to one of two arms:
Arm 1: Six weeks after surgery, women will learn about lymphedema risk and prevention through conversations and written materials. They will measure their arm and fill out a questionnaire after six weeks and six, 12 and 18 months. They will be contacted by phone at nine and 15 months.
Arm 2: Women will be given the same lymphedema education and will complete the same measurements and questionnaires completed by the women in arm 1. They also will follow a personalized exercise regimen and watch a 15-minute video that reinforces information and exercises.
After study completion, researchers will examine the following factors in each group to determine whether the exercise program was effective in reducing the number of cases of lymphedema:
- Severity of lymphedema in terms of arm circumference
- The agreement between the women’s perceptions of their swelling and the actual arm measurement
- Health-related quality of life
- Adherence to exercise regimen, knowledge of lymphedema, range of motion and arm strength
Am I Eligible to Participate?
You may be eligible if you are a woman over age 18 and:
- Are newly diagnosed with stage I-III breast cancer
- Have not been diagnosed with lymphedema
- Have an arm circumference less than or equal to 17 inches
- Are scheduled to undergo axillary node dissection with 10 or more nodes removed
Participants should not have had prior double mastectomy with axillary node dissection involving both arms. You may not be able to participate if you have other serious medical conditions or have had breast cancer before, including lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS). You may not participate if you only undergo a sentinel lymph node biopsy.
You may have had any type of radiotherapy to the breast or axilla or undergone neoadjuvant treatment, or treatment preceding surgery. You may be enrolled on other treatment trials, except surgery trials where one treatment arm involves full axillary node dissection.
For more information, contact: (800) 4-CANCER