Using electroacupuncture to enhance chemotherapy delivery for recurrent glioma

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

This study is testing if a special type of acupuncture can help deliver a chemotherapy drug more effectively to people with recurrent high-grade glioma who haven't had success with other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (China, Hangzhou City, Zhejiang Province)
• Trial ID: NCT06818331 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of Specific Mode Electroacupuncture Stimulation (SMES) combined with Paclitaxel in patients with recurrent high-grade glioma. The study aims to determine whether SMES can facilitate the delivery of Paclitaxel across the blood-brain barrier, which is a significant challenge in treating gliomas due to the drug's large molecular size. Participants will be monitored for treatment outcomes and any adverse effects associated with the intervention. The trial is designed as a single-arm study, focusing on patients who have previously failed standard treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with histologically confirmed high-grade glioma who have experienced recurrence after standard treatments.

Not a fit: Patients with low-grade gliomas or those who have not undergone surgical resection may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment options and outcomes for patients with recurrent glioma.

How similar studies have performed: Preliminary research suggests that similar approaches using electroacupuncture to enhance drug delivery across the blood-brain barrier have shown promise, but this specific combination is novel.

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.

Where this trial is running

China, Hangzhou City, Zhejiang Province

• The Third Affiliated Hospital of Zhejiang Chinese Medical University — China, Hangzhou City, Zhejiang Province, China (Recruiting)

Study contacts

• Study coordinator: Xianming Lin PHD

Conditions Glioma; glioma; Specific Mode Electroacupuncture Stimulation; Paclitaxel; blood-brain barrier