RecruitingPhase 2NCT06818331

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

Sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Enrollment

20 participants

Start Date

Feb 10, 2025

Study Type

INTERVENTIONAL

Conditions

Glioma

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a special type of acupuncture (electroacupuncture) can help deliver a chemotherapy drug called paclitaxel into the brain more effectively in patients whose brain tumor (glioblastoma, the most aggressive type) has come back after surgery. **You may be eligible if...** - You have been diagnosed with grade IV glioma (glioblastoma) that has returned after surgery - You are between 18 and 70 years old - Your tumor can be measured on an MRI scan - You have adequate blood counts and organ function - You are willing and able to receive electroacupuncture treatment **You may NOT be eligible if...** - You have uncontrolled seizures - You are currently in another clinical trial or finished one less than a month ago - You have previously received paclitaxel or similar drugs - You are allergic to paclitaxel - You are pregnant or breastfeeding - You have dementia or a significant cognitive condition - You have infected skin at acupuncture sites or metal implants in your body - You cannot have an MRI with contrast dye - You are currently receiving other anti-cancer treatments such as chemo or radiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSMES+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.

DRUGPaclitaxel

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

DEVICESpecific 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