protocolSection identificationModule nctId: NCT06330337, orgStudyIdInfo id: ZSLL-KY-2024-010-01, briefTitle: Effect of Electroacupuncture Combined With Paclitaxel Clinical Efficacy of Patients With Recurrence of High-grade Glioma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: The Third Affiliated hospital of Zhejiang Chinese Medical University, class: OTHER, collaborators name: Zhejiang University, descriptionModule briefSummary: 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., conditionsModule conditions: Glioma, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: Temozolomide（TMZ） injection or oral administration, interventions name: Albumin-Bound Paclitaxel(ABX) intravenous drip, interventions name: Specific mode electroacupuncture stimulation(SMES) intervention, outcomesModule primaryOutcomes measure: Overall survival（OS）, secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Head MRI (plain and enhanced), secondaryOutcomes measure: he Karnofsky Performance Score (KPS), secondaryOutcomes measure: The Eastern Cooperative Oncology Group (ECOG), secondaryOutcomes measure: The Quality of Life (QOL), secondaryOutcomes measure: The Neurological Assessment for Neuro-Oncology (NANO), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University, status: RECRUITING, city: Zhejiang, country: China, contacts name: Xianming Lin, PHD, role: CONTACT, phone: +86-13858028101, email: linxianming1966@163.com, contacts name: Zhaoxing Jia, PHD, role: CONTACT, phone: +86-18356130598, email: zhenxinzhenyi183@163.com, hasResults: False