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

Launched by THE THIRD AFFILIATED HOSPITAL OF ZHEJIANG CHINESE MEDICAL UNIVERSITY · Feb 5, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with high-grade gliomas, which are aggressive brain tumors that often come back after surgery. The study aims to see if a combination of a technique called Specific Mode Electroacupuncture Stimulation (SMES) and the chemotherapy drug Paclitaxel can safely help treat patients who have experienced a recurrence of their glioma. Paclitaxel is known to be a strong anti-cancer drug, but it usually cannot reach the brain due to a protective barrier called the blood-brain barrier. This trial will explore whether SMES can help open this barrier, allowing the drug to work effectively against the tumor.

To be eligible for the trial, participants must be between 18 and 70 years old, have a confirmed diagnosis of high-grade glioma that has returned after standard treatments, and be in a condition that allows them to undergo acupuncture. Participants should also have a stable daily dose of a steroid medication (if needed) and be able to communicate and understand pain. They cannot have uncontrolled seizures, severe nerve damage, or be pregnant or breastfeeding. If you join the trial, you will be closely monitored for safety and the effectiveness of this new treatment combination.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • 1. WHO grade IV glioma as defined in the "Integrated Diagnosis and Treatment Guidelines for Glioma of the Chinese Anti-Cancer Association" (V2.0_2025 (20250110)).
• • 2. Recurrence confirmed by cranial MRI after surgical resection.
• • 3. According to the Response Assessment in Neuro-Oncology Criteria, version 2.0 (RANO 2.0) standards, there is at least one measurable lesion.
• • 4. Age ≥ 18 years and ≤ 70 years, gender not limited.
• • 5. If dexamethasone is used due to the space-occupying effect, the stable daily dose within 7 days before enrollment should be \< 6 mg; if the dose of dexamethasone is being reduced, the average daily dose within 7 days before enrollment should be \< 6 mg. Patients receiving dexamethasone treatment for reasons other than the space-occupying effect can still be enrolled.
• • 6. Karnofsky Performance Status Score (KPS) ≥ 40 points or World Health Organization (WHO) Performance Status Score ≤ 3 points.
• • 7. Good bone marrow function, liver and kidney function (within 14 days before treatment): a. Hemoglobin ≥ 90.0 g/L; b. White blood cells ≥ 3.0\*10\^9/L; c. Absolute neutrophil count ≥ 1500/µL (white blood cell count \* neutrophil percentage); d. Platelets ≥ 100\*10\^9/µl; e. Total bilirubin (TbIL) ≤ 5.0 x ULN; f. Serum aspartate aminotransferase (SGOT) ≤ 3 x ULN and TbIL ≤ 3.0 x ULN; g. Creatinine ≤ 1.5 mg/dL, estimated glomerular filtration rate ≥ 30 mL/min to \< 90 mL/min)
• • 8. Able to receive electroacupuncture treatment and have good compliance.
• • 9. Clear consciousness, pain perception and discrimination ability, and basic communication ability.
• • 10. Signed the informed consent form and voluntarily participated in this study.
• • Exclusion criteria
• • 1. Seizure attack, uncontrollable.
• • 2. Those who are currently participating in other clinical trials or have completed other clinical trials within less than one month.
• • 3. Those who have received treatment containing paclitaxel or similar drugs.
• • 4. Those who have a severe allergy to paclitaxel or similar substances.
• • 5. Pregnant or lactating women.
• • 6. Those with diseases affecting cognitive function such as congenital dementia, or alcoholics, drug addicts or those with abuse of psychotropic substances.
• • 7. Those with infected skin at the acupuncture site.
• • 8. Patients with metallic foreign bodies in their bodies.
• • 9. Those who cannot undergo cranial enhanced MRI examination.
• • 10. Other acute or chronic diseases, mental disorders or abnormal laboratory test values that may increase the risk associated with participating in the study or the administration of the study drug, or interfere with the interpretation of study results, and the investigator determines that the patient does not meet the eligibility criteria for participation in the study.
• • 11. Those who are undergoing other types of anti-tumor treatments simultaneously during the trial, such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.