Early Intervention to Prevent Lower Limb Lymphedema of Gynecological Malignancy

Launched by CHONGQING UNIVERSITY CANCER HOSPITAL · Mar 20, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at ways to prevent swelling in the legs, known as lymphedema, in women who have certain types of gynecological cancers and are undergoing surgery and radiation treatment. The study will enroll 400 participants, who will be divided into two groups: one group will receive special preventive treatments to help reduce the risk of lymphedema, while the other group will receive standard care. The preventive treatment includes techniques like gentle massage, skin care, exercises, and wearing special compression stockings.

To be eligible for this trial, participants need to be women aged 18 to 60 who are receiving radiation therapy after having lymph node surgery for gynecological cancer. They should be in good overall health and able to commit to the study's requirements. Throughout the trial, participants will be monitored for any signs of swelling and asked about their quality of life. This study aims to see if early intervention can effectively reduce the risk of lymphedema and improve the well-being of patients.

Gender

FEMALE

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.