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Name of the Trial

Randomized Study of Education With or Without Exercise and Counseling in Preventing Lymphedema in Women With Stage I-III Breast Cancer Who Are Undergoing Axillary Lymph Node Dissection (CALGB-70305). See the protocol summary ³.

Principal Investigator

Dr. Electra Paskett, Cancer and Leukemia Group B.

Dr. Electra Paskett Principal Investigator

Why This Trial Is Important

Surgery for breast cancer may include the removal and examination of lymph nodes in the underarm area near the affected breast (called axillary node dissection). This procedure allows doctors to determine whether cancer has spread to the lymphatic system. A common side effect of axillary node dissection is lymphedema, a swelling of the arm and/or hand on the same side as surgery caused by the buildup of lymphatic fluid. Lymphedema is often debilitating.

There is no known cure for lymphedema, but some measures can make it easier to live with or possibly prevent it. Women who undergo axillary node dissection should receive education about how to recognize and possibly prevent lymphedema.

This study compares a lymphedema-prevention education program to the same education program supplemented with an exercise regimen and counseling in women who have been newly diagnosed with breast cancer and who will undergo axillary node dissection. Researchers want to see if education, exercise, and counseling will help prevent lymphedema or limit its severity if it develops.

"As many as one third of women who undergo full axillary node dissection will experience lymphedema," said Dr. Paskett. "These women may suffer serious physical, social, and psychological effects because of this condition. We hope these interventions will help breast cancer survivors enjoy a better quality of life."

Who Can Join This Trial

Researchers will enroll 560 women aged 18 and over newly diagnosed with stage I-III breast cancer who will undergo an axillary node dissection with 10 or more lymph nodes removed. See the list of eligibility criteria ⁴.

Study Sites and Contact Information

Study sites in the United States are recruiting patients for this study. See the list of study contacts ⁵ or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.

Glossary Terms

A rounded mass of lymphatic tissue that is surrounded by a capsule of connective tissue. Lymph nodes filter lymph (lymphatic fluid), and they store lymphocytes (white blood cells). They are located along lymphatic vessels. Also called lymph gland.

The tissues and organs that produce, store, and carry white blood cells that fight infections and other diseases. This system includes the bone marrow, spleen, thymus, lymph nodes, and lymphatic vessels (a network of thin tubes that carry lymph and white blood cells). Lymphatic vessels branch, like blood vessels, into all the tissues of the body.