Early Intervention to Prevent Lower Limb Lymphedema of Gynecological Malignancy
Early Intervention to Prevent Gynecological Malignant Tumors Clinical Study of Lymphedema of the Lower Limbs in Patients With Radiotherapy After Lymphadenectomy
Chongqing University Cancer Hospital
400 participants
Apr 1, 2023
INTERVENTIONAL
Conditions
Summary
This study is a prospective, randomized, controlled clinical trial of a single center in China and plans to enroll 400 patients. 1. Patients with diagnosed gynecological malignancies who underwent pelvic and abdominal lymphadenectomy and required pelvic radiotherapy; 2. Random grouping (A:B=3:1): A. Prophylactic lymphoedema treatment; B. Standard care group; 3. Preventive lymphedema health education was given to patients with gynecological malignant tumors without contraindications before surgery. All patients were randomly divided into an intervention group and a nonintervention group. The intervention group received preventive lymphedema treatment twice a week. 10 times, and the interval between the two treatments was not less than 48 hours and not more than 2 weeks. The intervention measures included four parts: manual lymphatic drainage, skin care, functional exercise, and wearing lymphedema preventive compression stockings. In the nonintervention group, knowledge education and telephone follow-up were routinely conducted. 4. All patients were evaluated for edema, lymphedema symptoms and quality of life 1 day before radiotherapy, every Friday during radiotherapy and every 3 months thereafter. Bioelectrical impedance measurement and leg diameter measurement were used to evaluate edema, the Gynecologic Cancer Lymphedema Questionnaire (GCLQ) was used to evaluate lymphedema symptoms, and the EORTC Quality of Life Scale (QLQ-C30) was used to evaluate quality of life. followed up to 2 years after the end of lymphedema prophylaxis.
Eligibility
Plain Language Summary
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Interventions
1\. perform manual lymphatic drainage twice a week after the start of radiotherapy for a total of 10 times, and wear lymphedema compression stockings after each manual lymphatic drainage, 2. teach patients how to care for their skin. 3. perform functional exercises for lymphedema of the lower extremities twice a day for 15 \~ 20 minutes each time. 4. follow up observation: before the start of radiotherapy, every Friday during radiotherapy, and every 3 months after the end of radiotherapy, the occurrence of lymphedema and related symptoms and quality of life were evaluated.
Locations(1)
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NCT05793749