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New treatment option for Uterine Cervical Neoplasms
Official title Early Intervention to Prevent Lower Limb Lymphedema of Gynecological Malignancy
ClinicalTrials.gov ID: NCT05793749
What this study is testing
- What it's testing
- This study is a prospective, randomized, controlled clinical trial of a single center in China and plans to enroll 400 patients. 1.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60, women only
You may be able to join if
- 1.Gynecologic oncology patients undergoing radiotherapy after lymph node surgery who voluntarily participate in this study and sign an informed...
- 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)...
- 6.serum alamine aminotransferase(ALT) and glutamic oxalacetic transaminase(AST) less than 2 times the normal value and creatinine less than 1.5 times...
- 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...
- 8.Ability to comply with the trial protocol, as judged by the investigator.
You likely can't join if
- Lymphedema and deep vein thrombosis of the lower extremities were clearly diagnosed;
- Acute infection of any kind;
- Patients with lower extremity edema;
- pregnancy, menstrual period;
- Recent major abdominal surgery (determined by the investigator);
- Radiation colitis, cystitis, intestinal infection, small bowel or large bowel diverticulitis or diverticulitis;
See the full eligibility 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...
- 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...
- 8.Ability to comply with the trial protocol, as judged by the investigator.
- Lymphedema and deep vein thrombosis of the lower extremities were clearly diagnosed;
- Acute infection of any kind;
- Patients with lower extremity edema;
- pregnancy, menstrual period;
- Recent major abdominal surgery (determined by the investigator);
- Radiation colitis, cystitis, intestinal infection, small bowel or large bowel diverticulitis or diverticulitis;
- Liver fibrosis;
- Abdominal aortic aneurysm;
- acute phlebitis;
- Severe arterial obstructive disease, arterial ulcer, ABPI (ankle-brachial blood pressure index) greater than 1.3 and less than 0.5;
- Severe peripheral neuropathy;
- Poor control of hypertension, poor control of stroke and diabetes, and severe bronchial asthma;
- Patients who cannot understand the experimental content and cannot cooperate and those who refuse to sign the informed consent;
- Those with concomitant diseases or other special circumstances that seriously endanger the patient's safety or affect the patient's completion of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.