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The Lymphedema and Gynecologic Cancer (LEG) Study: Incidence, Risk Factors, and Impact

Richard R Barakat

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National Institutes of Health (NIH)
The proposed study, "Lymphedema and Gynecologic cancer (LEG): Incidence, Risk Factors and Impact", will innovatively utilize the cooperative group setting of the GOG (Gynecologic Oncology Group) to prospectively study 1300 women newly diagnosed with cervical, endometrial, or vulvar cancer to determine the incidence and impact of lower extremity lymphedema following surgical treatment of these diseases. Study participants will be assessed preoperatively and postoperatively over a 24-month period with both objective and subjective measures to capture the incidence and risk factors for the development of lymphedema and its associated impact on quality of life. Lymphedema has been identified as a chronic, disruptive and disfiguring condition occurring in women undergoing radical cancer treatment. Although some data exist on this condition, the preponderance of research has focused on the area of upper extremity lymphedema following breast cancer surgery. Of the limited data addressing lymphedema in women with gynecologic cancer, methodical concerns exist, including retrospective study design and a lack of uniformity in the assessment and diagnosis of lymphedema. These issues have contributed to the continued misunderstanding and probable under-diagnosis of this important survivorship issue. The field of oncology requires a large prospective study to definitively document the prevalence of lower extremity lymphedema following surgical staging and adjuvant therapy for gynecologic malignancy, in addition to determining associated risk factors. The lack of empirical data on lower extremity lymphedema is a significant limitation in cancer research since it prevents us from understanding not only the risk and prevalence of lymphedema but also the implications of this chronic condition on the emotional well-being and quality of life of cancer survivors. The unique findings derived from this landmark prospective study, which takes advantage of the infrastructure and resources of the Gynecologic Oncology Group, will be essential in formulating meaningful intervention studies to target early identification and symptom management of lymphedema, and ultimately lead to the enhancement of the quality of life of gynecologic cancer survivors.

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