Lower Extremity LymphedemaPhase 4NCT06329167
Daphnetin Capsules for Lower Limb Lymphoedema Following Gynaecological Surgery
A Phase 4 study testing Daphnetin and Aescuven in people with Lower Extremity Lymphedema, run by The First Hospital of Jilin University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Lower Extremity Lymphedema
- What is being tested?
- Daphnetin and Aescuven
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2024to 31 Jul 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the 1st hospital of Jilin University
Changchun, Jilin
Xiaosen Li Li, +8618343116682, xiaosensen@jlu.edu.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Lower Extremity Lymphedema
- Being tested
- Daphnetin, Aescuven
- Keywords
- Lower Extremity Lymphedema, gynaecological malignancy surgery, daphnetin, Aescuven
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaphnetinDrug
Also called gradient compression stocking
150mg tid (3 capsules/time, 3 times daily) and gradient compression stockings.
AescuvenDrug
Also called gradient compression stocking
150mg (2 capsules/time, 2 times daily) and gradient compression stockings.
| Study group | Role | What they receive |
|---|---|---|
| Daphnetin treatment group | Experimental | Daphnetin capsule 150mg tid (3 capsules/time, 3 times daily) and gradient compression stockings. Receives: Drug: Daphnetin |
| Aescuven Forte group | Active comparator | Aescuven Forte oral tablet 150mg (2 capsules/time, 2 times daily) and gradient compression stockings. Receives: Drug: Aescuven |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: day 14, day 21, day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start25 Mar 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity LymphedemaStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songling Zhang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329167
- Sponsor's protocol ID
- 2024-HS-012
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Daphnetin Capsules for Lower Limb Lymphoedema Following Gynaecological Surgery
- ClinicalTrials.gov ID
- NCT06329167
- Acronym / sponsor ID
- 2024-HS-012
- Conditions
- Lower Extremity Lymphedema
- Keywords
- Lower Extremity Lymphedema, gynaecological malignancy surgery, daphnetin, Aescuven
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 25 Mar 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daphnetin treatment group | Experimental | Drug: DaphnetinDaphnetin capsule 150mg tid (3 capsules/time, 3 times daily) and gradient compression stockings. |
| Aescuven Forte group | Active comparator | Drug: AescuvenAescuven Forte oral tablet 150mg (2 capsules/time, 2 times daily) and gradient compression stockings. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaphnetinAlso: gradient compression stocking150mg tid (3 capsules/time, 3 times daily) and gradient compression stockings. | Drug | Daphnetin treatment group |
| AescuvenAlso: gradient compression stocking150mg (2 capsules/time, 2 times daily) and gradient compression stockings. | Drug | Aescuven Forte group |
Primary outcome
The difference in the circumference of the lower limbs
Time frame: day 14, day 21, day 28
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.
Gynaecological Cancer Lymphedema Questionnaire
Time frame: day 14, day 21, day 28
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).
Fibrinogen content
Time frame: day 14, day 21, day 28
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Daphnetin and Aescuven in people with Lower Extremity Lymphedema, run by The First Hospital of Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the circumference of the lower limbs (time frame: day 14, day 21, day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.