Can prophylactic rehabilitation reduce the occurrence of lower limb lymphedema in patients with gynecologic malignances?: a multicenter, controlled, open-label, randomized clinical trial

Abstract

BACKGROUND: Secondary lymphedema is a chronic condition that often results from oncological treatment procedures. This condition can significantly impact the functionality and quality of life of gynecological cancer survivors. While decongestive therapies are available for the treatment of diagnosed lymphedema, there is a currently lack of evidence on prophylactic measures to prevent its onset after gynecological pelvic lymphadenectomy. OBJECTIVE: The study aims to evaluate the effectiveness of prophylactic rehabilitation in reducing the risk of secondary lower limb lymphedema in patients undergoing surgery for gynecological cancer involving pelvic lymphadenectomy. Additionally, we will try to assess whether prophylactic rehabilitation leads to a higher quality of life compared to the control group, which will receive exclusively educational strategies. DESIGN AND PARTICIPANTS: This study is a multicenter, controlled, open label, randomized clinical trial conducted in four Catalan hospitals. The study population consists of patients with any gynecologic tumor who undergo pelvic lymphadenectomy as part of their oncology treatment. The sample will be composed of 140 patients who meet the inclusion criteria, with 70 in the intervention group and 70 in the control group. METHODS: The main dependent variable will be to assess the presence or absence of lower limb lymphedema. The secondary dependent variable will be the evaluation of quality of life. Covariates that may affect the outcomes will be included. Patients will be randomly assigned into two groups: the control group, which will receive the current protocol based on educational strategies, and the intervention group, which will receive prophylactic decongestive therapy, in addition to the same educational strategy. The intervention will last for 12 weeks, and we will follow-up these patients for 24 months. The occurrence of lymphedema and quality of life will be analyzed and compared between the two different groups