RecruitingPhase 3NCT06330337

Effect of Electroacupuncture Combined With Paclitaxel Clinical Efficacy of Patients With Recurrence of High-grade Glioma

Specific Model Electroacupuncture Stimulation Promotes Paclitaxel Delivery Across the BBB for Postoperative Glioma Patients: A Randomized Controlled Study

Sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Enrollment

58 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Glioma

Summary

Gliomas are the most common type of primary brain tumors, with surgery followed by radiotherapy and chemotherapy as the main treatment modalities. However, they are highly prone to recurrence, presenting significant treatment challenges, especially for high-grade gliomas, which have a 5-year survival rate of only 5.5%. Paclitaxel, a common chemotherapeutic agent, exhibits antitumor effects in vitro that are 1400 times stronger than those 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, precluding 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 blood-brain barrier, enhancing the concentration of albumin-bound paclitaxel (ABX) in tumor tissues, peritumoral tissues, and surrounding invasive tissues, thereby exerting antitumor effects. Consequently, this study aims to observe the safety and efficacy of SMES combined with ABX in treating patients with recurrent high-grade gliomas postoperatively, to explore its mechanisms of action, extend survival, improve quality of life, and forge new theories and methods for the integrative treatment of brain tumors combining traditional Chinese and Western medicine.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding electroacupuncture (a form of acupuncture that uses mild electrical stimulation) to standard chemotherapy with paclitaxel can improve outcomes for people with high-grade glioma (an aggressive brain tumor) that has come back after initial treatment. Researchers hope the combination may improve tumor control or quality of life. **You may be eligible if:** - You have been confirmed by biopsy to have a high-grade glioma that has recurred after standard surgery, radiation, and chemotherapy - You are between 18 and 70 years old - Your physical ability and neurological function meet minimum requirements for treatment - You are mentally alert, can communicate, and can feel and distinguish pain (needed for acupuncture) - If you take steroids for brain swelling, your dose is stable and low **You may NOT be eligible if:** - You have uncontrolled seizures - You have significant nerve damage (peripheral neuropathy above grade 1) - You have previously been treated with paclitaxel or similar drugs, or are allergic to them - You are currently enrolled in another clinical trial - You have severe heart, liver, kidney, or blood problems 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

DRUGTemozolomide（TMZ） injection or oral administration

Oral administration of TMZ150-200mg/m2/ day, continuous use for 5 days, discontinued for 23 days, for a treatment cycle, a total of 6 cycles.

DRUGAlbumin-Bound Paclitaxel(ABX) intravenous drip

ABX was administered intravenously at a dose of 110mg/m2 on days 1 and 8 of a 28-day treatment cycle

DEVICESpecific mode electroacupuncture stimulation(SMES) intervention

Patients take supine position. After skin disinfection with 75% ethanol routine disinfection, the stainless needle (size 0.25mm×40mm, Hua Tuo brand, Suzhou Medical Supplies Company Ltd in Jiangsu, China) will be inserted in GV20（Baihui) and the stainless needle(size 0.25mm×25mm, described above) will be inserted in GV26 (Shuigou), acupoints will be stimulated manually until patients feel soreness, distension or heaviness (the reaction of "De Qi"). Then, the needles are stimulated by using an acupuncture point nerve stimulator (HANS-200, Nanjing Jinsheng, Ltd., China) 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).The 28-day treatment cycle was followed by simultaneous intervention with ABX on days 1 and 8.