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

PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

February 10, 2025

Primary Completion Date

February 24, 2028

Study Completion Date

February 24, 2028

Conditions
Glioma
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"

Trial Locations (1)

310000

RECRUITING

The Third Affiliated Hospital of Zhejiang Chinese Medical University, China

All Listed Sponsors
lead

The Third Affiliated hospital of Zhejiang Chinese Medical University

OTHER