NCT06818331

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-02-10
• Primary completion: 2028-02-24
• Completion: 2028-02-24
• First posted: 2025-02-10
• Last updated: 2025-06-04

Locations

1 site across 1 country: China