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

Get Involved

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

Study Purpose

Gliomas are the most common type of primary brain tumors, with the main treatment modalities including surgery, radiotherapy, and chemotherapy. However, gliomas are highly prone to recurrence, posing significant treatment challenges, especially for high-grade gliomas, which have a 5-year survival rate of only 5.5%. Paclitaxel (PTX) is a common chemotherapeutic agent, and its in vitro antitumor efficacy is 1400 times stronger than that of temozolomide (the first-line chemotherapy drug for gliomas). However, due to its large molecular weight (approximately 893 Da), it cannot cross the blood-brain barrier (BBB), preventing its use as a first-line treatment for gliomas. Preliminary research by our team has demonstrated that Specific Mode Electroacupuncture Stimulation (SMES) can open the BBB, increasing the concentration of PTX in tumor tissues, peritumoral tissues, and surrounding invasive tissues, thereby exerting antitumor effects. Therefore, this study aims to preliminarily observe the safety and efficacy of SMES combined with PTX in treating patients with postoperative recurrent high-grade gliomas.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Histologically diagnosed as high-grade glioma, failed standard radiotherapy and chemotherapy after surgical resection, with radiological confirmation of recurrence. 2. Aged ≥18 and ≤70 years, regardless of gender. 3. If dexamethasone is administered due to mass effect, the stable daily dose of dexamethasone within 7 days prior to enrollment must be <6 mg, or if the dexamethasone dose is being reduced, the average daily dose within 7 days prior to enrollment must be <6 mg. Patients who receive dexamethasone for reasons other than mass effect may still be eligible for enrollment. 4. Karnofsky performance score ≥40 or WHO performance status score ≤3. 5. Meets the indications for acupuncture therapy, with no severe complications, capable of accepting acupuncture treatment, and demonstrating good compliance. 6. Clear consciousness, able to perceive and distinguish pain, and able to communicate at a basic level. 7. Signed informed consent form and voluntarily agreed to participate in this study.

Exclusion Criteria:

- 1.

Uncontrolled seizures. 2. Peripheral neuropathy > Grade 1. 3. Currently participating in another clinical trial or have participated in another clinical trial within the past 3 months. 4. Prior treatment with paclitaxel-like chemical or biological compounds, or a history of allergic reactions. 5. Severe dysfunction of the heart, liver, kidneys, or hematologic system (within 14 days prior to treatment: a. Hemoglobin ≥ 90.0 g/L; b. White blood cell count ≥ 3.0 × 10^9/L; c. Absolute neutrophil count ≥ 1500/µL (white blood cell count × neutrophil percentage); d. Platelet count ≥ 100 × 10^9/µL; e. Total bilirubin (TbIL) ≤ 5.0 × ULN; f. Serum AST (SGOT) ≤ 3 × ULN and TbIL ≤ 3.0 × ULN; g. Serum creatinine ≤ 1.5 mg/dL, estimated creatinine clearance ≥ 30 mL/min to < 90 mL/min). 6. Pregnant or breastfeeding women. 7. Diseases affecting cognitive function, such as congenital dementia, or individuals with a history of alcohol, drug, or psychotropic substance abuse.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06818331
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2/Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The Third Affiliated hospital of Zhejiang Chinese Medical University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma

Arms & Interventions

Arms

Experimental: 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).

Interventions

Other: - 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.

Drug: - Paclitaxel

Paclitaxel is administered intravenously at a dose of 135-175mg/m², repeated every 3 weeks.

Device: - 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