To hear about similar clinical trials, please enter your email below
Trial Title:
Daphnetin Capsules for Lower Limb Lymphoedema Following Gynaecological Surgery
NCT ID:
NCT06329167
Condition:
Lower Extremity Lymphedema
Conditions: Official terms:
Lymphedema
Conditions: Keywords:
Lower Extremity Lymphedema
gynaecological malignancy surgery
daphnetin
Aescuven
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Daphnetin
Description:
150mg tid (3 capsules/time, 3 times daily) and gradient compression stockings.
Arm group label:
Daphnetin treatment group
Other name:
gradient compression stocking
Intervention type:
Drug
Intervention name:
Aescuven
Description:
150mg (2 capsules/time, 2 times daily) and gradient compression stockings.
Arm group label:
Aescuven Forte group
Other name:
gradient compression stocking
Summary:
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.
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.
Criteria for 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.
Gender:
Female
Gender based:
Yes
Gender description:
female after gynaecological malignancy surgery
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
the 1st hospital of Jilin University
Address:
City:
Chang Chun
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaosen Li Li
Phone:
+8618343116682
Email:
xiaosensen@jlu.edu.cn
Start date:
March 25, 2024
Completion date:
July 31, 2025
Lead sponsor:
Agency:
The First Hospital of Jilin University
Agency class:
Other
Source:
The First Hospital of Jilin University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06329167