Evaluation of Clinical Efficacy and Safety of Specific Mode Electroacupuncture Stimulation for Paclitaxel Across BBB Delivery in Patients With Postoperative Recurrence of Malignant Glioma: A Single-arm Trial
NCT ID: NCT06818331
Last Updated: 2025-06-04
Study Results
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Basic Information
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RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2025-02-10
2028-02-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment group
Patients in the treatment group received both paclitaxel(PTX) and a specific mode electroacupuncture stimulation（SMES） .
Drug: Paclitaxel is administered intravenously at a dose of 135-175mg/m², repeated every 3 weeks.
Device: SMES immediately after the ABX intravenous infusion began, the patient was placed in a supine position, the skin was routinely disinfected with 75% ethanol, and a stainless steel needle was inserted into GV20 and GV26.Then, the needles are stimulated by using an acupuncture point nerve stimulator with a frequency of 2/100 Hz and an intensity of 3 mA for 40 min (a homemade relay cycled power to the electrode for 6 sec on and 6 sec off).
SMES+PTX
This intervention involves the combined use of medication and device, where the specific mode electroacupuncture stimulation (SMES) intervention is administered simultaneously with the intravenous infusion of paclitaxel.
Paclitaxel
Paclitaxel is administered intravenously at a dose of 135-175mg/m², repeated every 3 weeks.
Specific mode electroacupuncture stimulation
Patients assume a supine position. After routine skin disinfection with 75% ethanol, a stainless steel needle (size 0.25mm×40mm) is inserted into GV20 (Baihui), and another stainless steel needle (size 0.25mm×25mm, as described above) is inserted into GV26 (Shuigou). The acupoints are manually stimulated until the patient experiences soreness, distension, or heaviness (the "De Qi" response). Subsequently, the needles are stimulated using an acupuncture point nerve stimulator (HANS-200, Nanjing Jinsheng Ltd., China) at a frequency of 2/100 Hz and an intensity of 3 mA for 40 minutes (a homemade relay cycled power supply to the electrode, with 6 seconds on and 6 seconds off). The intervention is administered every three weeks, concurrently with paclitaxel treatment
Interventions
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SMES+PTX
This intervention involves the combined use of medication and device, where the specific mode electroacupuncture stimulation (SMES) intervention is administered simultaneously with the intravenous infusion of paclitaxel.
Paclitaxel
Paclitaxel is administered intravenously at a dose of 135-175mg/m², repeated every 3 weeks.
Specific mode electroacupuncture stimulation
Patients assume a supine position. After routine skin disinfection with 75% ethanol, a stainless steel needle (size 0.25mm×40mm) is inserted into GV20 (Baihui), and another stainless steel needle (size 0.25mm×25mm, as described above) is inserted into GV26 (Shuigou). The acupoints are manually stimulated until the patient experiences soreness, distension, or heaviness (the "De Qi" response). Subsequently, the needles are stimulated using an acupuncture point nerve stimulator (HANS-200, Nanjing Jinsheng Ltd., China) at a frequency of 2/100 Hz and an intensity of 3 mA for 40 minutes (a homemade relay cycled power supply to the electrode, with 6 seconds on and 6 seconds off). The intervention is administered every three weeks, concurrently with paclitaxel treatment
Eligibility Criteria
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Inclusion Criteria
2. Recurrence confirmed by cranial MRI after surgical resection.
3. According to the Response Assessment in Neuro-Oncology Criteria, version 2.0 (RANO 2.0) standards, there is at least one measurable lesion.
4. Age ≥ 18 years and ≤ 70 years, gender not limited.
5. If dexamethasone is used due to the space-occupying effect, the stable daily dose within 7 days before enrollment should be \< 6 mg; if the dose of dexamethasone is being reduced, the average daily dose within 7 days before enrollment should be \< 6 mg. Patients receiving dexamethasone treatment for reasons other than the space-occupying effect can still be enrolled.
6. Karnofsky Performance Status Score (KPS) ≥ 40 points or World Health Organization (WHO) Performance Status Score ≤ 3 points.
7. Good bone marrow function, liver and kidney function (within 14 days before treatment): a. Hemoglobin ≥ 90.0 g/L; b. White blood cells ≥ 3.0\*10\^9/L; c. Absolute neutrophil count ≥ 1500/µL (white blood cell count \* neutrophil percentage); d. Platelets ≥ 100\*10\^9/µl; e. Total bilirubin (TbIL) ≤ 5.0 x ULN; f. Serum aspartate aminotransferase (SGOT) ≤ 3 x ULN and TbIL ≤ 3.0 x ULN; g. Creatinine ≤ 1.5 mg/dL, estimated glomerular filtration rate ≥ 30 mL/min to \< 90 mL/min)
8. Able to receive electroacupuncture treatment and have good compliance.
9. Clear consciousness, pain perception and discrimination ability, and basic communication ability.
10. Signed the informed consent form and voluntarily participated in this study.
Exclusion Criteria
2. Those who are currently participating in other clinical trials or have completed other clinical trials within less than one month.
3. Those who have received treatment containing paclitaxel or similar drugs.
4. Those who have a severe allergy to paclitaxel or similar substances.
5. Pregnant or lactating women.
6. Those with diseases affecting cognitive function such as congenital dementia, or alcoholics, drug addicts or those with abuse of psychotropic substances.
7. Those with infected skin at the acupuncture site.
8. Patients with metallic foreign bodies in their bodies.
9. Those who cannot undergo cranial enhanced MRI examination.
10. Other acute or chronic diseases, mental disorders or abnormal laboratory test values that may increase the risk associated with participating in the study or the administration of the study drug, or interfere with the interpretation of study results, and the investigator determines that the patient does not meet the eligibility criteria for participation in the study.
11. Those who are undergoing other types of anti-tumor treatments simultaneously during the trial, such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.
18 Years
70 Years
ALL
No
Sponsors
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The Third Affiliated hospital of Zhejiang Chinese Medical University
OTHER
Responsible Party
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Xianming Lin
Clinical Professor
Locations
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The Third Affiliated Hospital of Zhejiang Chinese Medical University
China, Hangzhou City, Zhejiang Province, China
Countries
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Central Contacts
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Facility Contacts
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Jia
Role: backup
References
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Other Identifiers
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ZSLL-KY-2024-079-01
Identifier Type: -
Identifier Source: org_study_id
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