NCT05793749 Early Intervention to Prevent Lower Limb Lymphedema of Gynecological Malignancy

Eligibility & Interventions

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This trial targets 400 participants in total. It began in 2023-04-01 with a primary completion date of 2026-07-29.

Brief 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 Criteria

Inclusion Criteria: 1.Gynecologic oncology patients undergoing radiotherapy after lymph node surgery who voluntarily participate in this study and sign an informed consent form. 2.18 to 60 years old. 3.Eastern Cooperative Oncology Group（ECOG) score less than 2. 4.Expected survival time greater than 3 years. 5.Hemoglobin(Hb) greater than or equal to 70 g/L, white blood cells (WBC)greater than or equal to 3.5 × 109 /L, neutrophils(ANC)greater than or equal to 1.5 × 109 /L, platelets (PLT)greater than or equal to 80 × 109 /L. 6.serum alamine aminotransferase(ALT) and glutamic oxalacetic transaminase(AST) less than 2 times the normal value and creatinine less than 1.5 times the normal value, albumin greater than or equal to 35g/L. 7.Women of childbearing potential must have had a pregnancy test (serum or urine) within 7 days prior to enrollment and have a negative result and be willing to use an appropriate method of contraception for the duration of the trial. 8.Ability to comply with the trial protocol, as judged by the investigator. Exclusion Criteria: 1. Lymphedema and deep vein thrombosis of the lower extremities were clearly diagnosed; 2. Acute infection of any kind; 3. Patients with lower extremity edema; 4. pregnancy, menstrual period; 5. Recent major abdominal surgery (determined by the investigator); 6. Radiation colitis, cystitis, intestinal infection, small bowel or large bowel diverticulitis or diverticulitis; 7. Liver fibrosis; 8. Abdominal aortic aneurysm; 9. acute phlebitis; 10. Severe arterial obstructive disease, arterial ulcer, ABPI (ankle-brachial blood pressure index) greater than 1.3 and less than 0.5; 11. Severe peripheral neuropathy; 12. Poor control of hypertension, poor control of stroke and diabetes, and severe bronchial asthma; 13. Patients who cannot understand the experimental content and cannot cooperate and those who refuse to sign the informed consent; 14. Those with concomitant diseases or other special circumstances that seriously endanger the patient's safety or affect the patient's completion of the study.

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