💬In plain words
What the trial is, and whether it could suit you
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, peritum
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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What it tests
- Temozolomide（TMZ） injection or oral administration
- Albumin-Bound Paclitaxel(ABX) intravenous drip
- Specific mode electroacupuncture stimulation(SMES) intervention
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Zhejiang, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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