Clinical trial NCT06330337: Effect of Electroacupuncture Combined With Paclitaxel Clinical Efficacy of Patients With Recurrence of High-grade Glioma
Official title: Specific Model Electroacupuncture Stimulation Promotes Paclitaxel Delivery Across the BBB for Postoperative Glioma Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Glioma
Keywords: glioma
Specific Mode Electroacupuncture Stimulation
protein-bound paclitaxel
blood-brain barrier
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
Collaborators: name: Zhejiang University
First posted: 2024-03-26
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Overall survival（OS）
timeFrame: Starting from randomization, during the follow-up phase, telephone follow-ups to record survival status are conducted every two months, totaling six follow-ups. This structured approach ensures a comprehensive assessment of patient out
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to 12 months were assessed from the date of randomization to the date of first recording to the date of progression or the date of death from any cause, whichever came first
measure: Head MRI (plain and enhanced)
timeFrame: One treatment cycle is 28 days, with cranial MRI scans conducted one day before the start of treatment cycles 1, 3, and 5, and at the end of treatment cycle 6.
measure: he Karnofsky Performance Score (KPS)
timeFrame: One treatment cycle is 28 days, with assessments conducted one day before the start of treatment cycles 1 through 6 and one day before the end of treatment cycle 6.
measure: The Eastern Cooperative Oncology Group (ECOG)
timeFrame: One treatment cycle is 28 days, with assessments conducted one day before the start of treatment cycles 1 through 6 and one day before the end of treatment cycle 6.
measure: The Quality of Life (QOL)
timeFrame: One treatment cycle is 28 days, with assessments conducted one day before the start of treatment cycles 1 through 6 and one day before the end of treatment cycle 6.
measure: The Neurological Assessment for Neuro-Oncology (NANO)
timeFrame: One treatment cycle is 28 days, with assessments conducted one day before the start of treatment cycles 1 through 6 and one day before the end of treatment cycle 6.
Other outcomes:
Locations:
city: Zhejiang
country: China
facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University
Study officials:
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