Daphnetin capsules for treating lower limb swelling after gynecological surgery

Clinical Trial of Daphnetin Capsules for Lower Limb Lymphoedema Following Gynaecological Surgery

This study is testing if Daphnetin capsules can help reduce swelling in the legs after gynecological cancer surgery better than standard treatment.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: The First Hospital of Jilin University (Academic / other)
• Drugs / interventions: Prednisone
• Locations: 1 site (Chang Chun, Jilin)
• Trial ID: NCT06329167 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy of Daphnetin capsules in treating lower limb lymphedema that occurs after gynecological surgery for cancer. Participants will receive either Daphnetin capsules or Aescuven tablets alongside gradient compression stockings for a duration of 21 days. The study is a randomized, controlled, open-label trial involving 100 patients, who will be monitored for safety and effectiveness of the treatment. The goal is to determine if Daphnetin can provide a better outcome compared to the standard treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with stage I-II lower limb lymphedema following gynecological cancer surgery.

Not a fit: Patients with pre-existing lymphedema or those with conditions causing lower limb edema may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of lower limb lymphedema in patients post-surgery, enhancing their quality of life.

How similar studies have performed: While this approach is novel in this specific context, similar studies have shown promise in treating lymphedema with other interventions.

Eligibility criteria

Inclusion Criteria:

* Patients aged 18 to 75 years (including cut-off) with lower limb lymphoedema (stage I-II) following gynaecological surgery for a malignant tumour without temporary surgical treatment.
* There was no preoperative lymphedema
* Voluntarily sign consent form
* The performance status score had to be 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG).
* Investigator-assessed expected survival ≥12 weeks
* Not receiving any other treatment for lower limb lymphoedema
* Have adequate organ and bone marrow reserve function
* Be able to understand the requirements of the trial and be willing and able to follow the trial and follow-up procedures

Exclusion Criteria:

* A history of severe trauma to the lower limbs;
* Diseases that can cause lower limb oedema such as primary lymphatic disease, venous thrombosis, cardiogenic, nephrogenic, hypoproteinemia and other systemic diseases that can cause lower limb oedema.
* Colour Doppler ultrasonography of the lower limbs suggesting lower limb vascular disease;
* Patients with a history of allogeneic cell or solid organ transplantation;
* primary central nervous system tumour or symptomatic central nervous system metastasis, meningeal metastasis, or history of epilepsy. Patients with clinically controlled CNS metastases that were asymptomatic or symptomatic but stable in the opinion of the investigators were eligible if the following conditions were met: a. Clinical symptoms were stable for more than 4 weeks prior to the first dose; b. No evidence of CNS disease progression on contrast-enhanced MRI of the head within 4 weeks prior to the first dose; c. Prednisone ≤10 mg/day or equivalent hormone dose was discontinued at least 2 weeks prior to the first dose of antiepileptic drugs.;
* other active malignancies within 5 years prior to the first dose. Except for locally cured tumours (such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, or carcinoma in situ of the breast);
* Any of the following cardiovascular diseases occurring within 6 months prior to the first dose of the drug: symptomatic heart failure of New York Heart Association (NYHA) class 2 or higher, left ventricular ejection fraction (LVEF) less than 50%, unstable arrhythmia, or unstable angina, Myocardial infarction requiring treatment, pulmonary embolism, or uncontrolled hypertension, defined in this protocol as systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg after treatment and clinically significant as assessed by the investigator);
* The presence of any other medical condition, physical examination, or laboratory test results that, in the opinion of the investigator, are unsuitable for use of the study drug;
* combined with long-term oral vitamin K disease
* Subjects with untreated or treated tuberculosis, including but not limited to tuberculosis; patients who received standard anti-tuberculosis treatment and were confirmed cured by the investigators were eligible.
* Severe infection had occurred within 4 weeks or active infection had occurred within 2 weeks prior to the first medication;
* Patients with the following diseases: human immunodeficiency virus (HIV) infection; active hepatitis B virus infection \[hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA (HBV DNA) \>200 IU/mL or 103 copies/mL\]; hepatitis C virus infection (HCV antibody and viral RNA (HCV RNA) test results were positive); patients with Treponema pallidum antibody positive and RPR positive;
* Known hypersensitivity or delayed allergic reaction to any component of the study drug;
* Known history of mental disorders, drug abuse, alcoholism, or substance abuse that may affect the test results;
* the patient's lack of compliance to participate in the clinical trial or the presence of any other factor that the investigator deems inappropriate for participation in the trial.
* patients with tumour recurrence or metastasis during follow-up.

Where this trial is running

Chang Chun, Jilin

• the 1st hospital of Jilin University — Chang Chun, Jilin, China (Recruiting)

Conditions Lower Extremity Lymphedema; gynaecological malignancy surgery; daphnetin; Aescuven