Daphnetin Capsules for Lower Limb Lymphoedema Following Gynaecological Surgery

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

This clinical trial is designed to learn more about treating patients with lower limb lymphoedema following gynaecological surgery. The main question to be answered is To evaluate the efficacy of Daphnetin capsule in the treatment of patients with lower limb lymphedema following gynaecological malignancy surgery. Participants will take Daphnetin capsule 150mg tid (3 capsules/time, 3 times daily) orally at the same time as gradient compression stocking treatment. Researchers will compare 150mg Forte tablets (2 capsules/time, 2 times daily) and gradient compression stockings to see if Daphnetin capsule can be used to treat patients with lower extremity lymphedema following gynaecological malignancy surgery.

Study Overview

• Status: Recruiting
• Conditions: Lower Extremity Lymphedema
• Intervention / Treatment: Drug: Daphnetin; Drug: Aescuven

Detailed Description

This study was a randomised, controlled, open-label, single-centre clinical trial. The objective of this study was to determine the efficacy and safety of Daphnetic capsules compared to Aesculete tablets in the treatment of patients with lower extremity lymphedema following gynaecological cancer surgery. A total of 100 patients with postoperative lower extremity lymphedema (stage I-II) following gynaecological cancer surgery were enrolled in this randomised controlled trial. Patients were randomised 1:1 to the experimental or control group.

Subjects who met the inclusion and exclusion criteria were randomly allocated to the Daphnetin group (study group) or the Aesculeum aesculeum group (control group) in a 1:1 ratio after signing the informed consent form. Both groups were treated for 21 days as a cycle, and efficacy and safety indices were evaluated after the first course of treatment.

Group A: Daphnetin capsule 150mg tid (3 capsules/time, 3 times daily) and gradient compression stockings.

Group B: Aescuven Forte oral tablet 150mg (2 capsules/time, 2 times daily) and gradient compression stockings.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jilin
    • Chang Chun, Jilin, China
      • Recruiting
      • The 1st Hospital Of Jilin University
      • Contact: Xiaosen Li Li; Phone Number: +8618343116682; Email: xiaosensen@jlu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Daphnetin treatment group; Daphnetin capsule 150mg tid (3 capsules/time, 3 times daily) and gradient compression stockings.	Drug: Daphnetin; 150mg tid (3 capsules/time, 3 times daily) and gradient compression stockings.; Other Names: gradient compression stocking
Active Comparator: Aescuven Forte group; Aescuven Forte oral tablet 150mg (2 capsules/time, 2 times daily) and gradient compression stockings.	Drug: Aescuven; 150mg (2 capsules/time, 2 times daily) and gradient compression stockings.; Other Names: gradient compression stocking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference in the circumference of the lower limbs	The patient was in the supine position with both lower limbs relaxed. The clinician measured the limb circumference at the dorsum of the foot, the lateral malleolus, the upper edge of the patella and 10 cm above and below with a tape measure and calculated the difference in limb circumference between the two lower limbs.	day 14, day 21, day 28
Gynaecological Cancer Lymphedema Questionnaire	The GCLQ has good reliability and validity and is easy to administer. It is widely used in the diagnosis and assessment of lower extremity lymphoedema. The questionnaire consisted of 20 questions scored on 7 dimensions: heaviness, oedema (global), swelling (local), numbness, infection, pain and limb function. The answer 'yes' to each question was worth 1 point and the answer 'no' was worth 0 point. A total score of ≥4 points was considered to be lower limb lymphedema (see Appendix II).	day 14, day 21, day 28
Fibrinogen content	2ml of peripheral venous blood was collected from patients and stored in EDTA anticoagulant test tubes. FIB was detected by automatic haemagglutination analyser (STAGO MAXR) in the laboratory department of our hospital.	day 14, day 21, day 28

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Estimated): March 25, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Lower Extremity Lymphedema; gynaecological malignancy surgery; daphnetin; Aescuven
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 2024-HS-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No