Electroacupuncture and Paclitaxel for High-Grade Glioma Recurrence

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

This study is testing whether combining acupuncture with a special cancer drug can help people with recurring high-grade glioma feel better when other treatments haven't worked.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Zhejiang)
• Trial ID: NCT06330337 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the combined effect of Specific Mode Electroacupuncture Stimulation (SMES) and Albumin-Bound Paclitaxel (ABX) in patients with recurrent high-grade glioma. The study aims to enhance the delivery of paclitaxel across the blood-brain barrier, which is typically a challenge due to the drug's large molecular weight. Participants will receive either temozolomide or ABX alongside the acupuncture intervention to assess improvements in treatment efficacy. The trial focuses on patients whose previous treatments have failed and who meet specific eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with histologically confirmed high-grade glioma who have experienced treatment failure.

Not a fit: Patients with low performance status or those who cannot comply with acupuncture treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with recurrent high-grade glioma.

How similar studies have performed: While the combination of acupuncture and chemotherapy is innovative, preliminary studies suggest potential benefits, though this specific approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Histologically confirmed high-grade glioma, with standard radiotherapy and chemotherapy post-surgical resection deemed unsuccessful, and recurrence confirmed by imaging.
2. Age ≥18 and ≤70 years, open to all genders.
3. If receiving dexamethasone for mass effect, a stable daily dose of \<6 mg in the 7 days prior to enrollment, or if the dose of dexamethasone is decreasing, an average daily dose of \<6 mg in the 7 days prior to enrollment. Patients receiving dexamethasone for reasons other than mass effect are still eligible.
4. A Karnofsky Performance Score (KPS) ≥70 or a World Health Organization (WHO) performance status of ≤2.
5. Meets the criteria for acupuncture, with no severe complications, able to undergo acupuncture treatment and demonstrates good compliance.
6. Clear consciousness, with the ability to perceive and distinguish pain, and capable of basic communication.
7. Signed informed consent, voluntarily participating in this study.

Exclusion Criteria:

1. Uncontrolled epileptic seizures;
2. Peripheral neuropathy \> Grade 1;
3. Currently participating in another clinical trial or having participated in a clinical trial that concluded less than 3 months ago;
4. Previous treatment with paclitaxel or similar chemotherapeutic or biologic agents, or history of allergic reactions to these compounds;
5. Patients with severe cardiac, hepatic, renal, or hematologic dysfunction (criteria within 14 days prior to treatment include: a. Hemoglobin ≥ 90.0 g/L; b. White blood cells ≥ 3.010\^9/L; c. Absolute neutrophil count ≥ 1500/µL; d. Platelets ≥ 10010\^9/µL; e. Total bilirubin (TbIL) ≤5.0 x ULN; f. Serum aspartate aminotransferase (SGOT) ≤10 x ULN and TbIL \>3 to ≤5.0 x ULN; g. Creatinine ≤1.5 mg/dL, estimated creatinine clearance ≥ 30 mL/min to \<90 mL/min);
6. Pregnant or breastfeeding women;
7. Individuals with cognitive impairments such as congenital dementia, or with histories of alcohol, drug, or psychotropic substance abuse;
8. Individuals with a history of needle fainting or infections at the site of acupuncture;
9. Patients with conductive foreign bodies within the body;
10. Individuals unable to undergo enhanced MRI examinations.

Where this trial is running

Zhejiang

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

Study contacts

• Study coordinator: Xianming Lin, PHD

Conditions Glioma; glioma; Specific Mode Electroacupuncture Stimulation; protein-bound paclitaxel; blood-brain barrier