Preventing lower limb lymphedema in women with gynecological cancers
Early Intervention to Prevent Gynecological Malignant Tumors Clinical Study of Lymphedema of the Lower Limbs in Patients With Radiotherapy After Lymphadenectomy
This study is testing if a special treatment plan can help prevent swelling in the legs for women with gynecological cancers who are getting surgery and radiation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Chongqing University Cancer Hospital Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT05793749 on ClinicalTrials.gov |
What this trial studies
This clinical trial is designed to evaluate the effectiveness of early intervention in preventing lower limb lymphedema in patients with gynecological malignancies who are undergoing pelvic and abdominal lymphadenectomy and require pelvic radiotherapy. The study will enroll 400 patients and randomly assign them to either a prophylactic treatment group or a standard care group. The intervention includes manual lymphatic drainage, skin care, functional exercise, and the use of compression stockings, administered twice a week. The aim is to assess whether these preventive measures can reduce the incidence of lymphedema compared to standard care.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 60 with gynecological malignancies undergoing radiotherapy after lymph node surgery.
Not a fit: Patients with contraindications to the intervention or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of lymphedema in women undergoing treatment for gynecological cancers.
How similar studies have performed: Other studies have shown promising results with similar preventive approaches for lymphedema, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chongqing, Chongqing Municipality
- Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Dongling Zou, Doctor
- Email: cqzl_zdl@163.com
- Phone: +8613657690699
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.