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Gliomas are the most common type of primary brain tumors, with the main treatment modalities including surgery, radiotherapy, and chemotherapy. However, gliomas are highly prone to recurrence, posing significant treatment challenges, especially for high-grade gliomas, which have a 5-year survival rate of only 5.5%. Paclitaxel (PTX) is a common chemotherapeutic agent, and its in vitro antitumor efficacy is 1400 times stronger than that 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 (BBB), preventing 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 BBB, increasing the concentration of PTX in tumor tissues, peritumoral tissues, and surrounding invasive tissues, thereby exerting antitumor effects. Therefore, this study aims to preliminarily observe the safety and efficacy of SMES combined with PTX in treating patients with postoperative recurrent high-grade gliomas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Patients in the treatment group received both paclitaxel(PTX) and a specific mode electroacupuncture stimulation（SMES） . Drug: Paclitaxel is administered intravenously at a dose of 135-175mg/m², repeated every 3 weeks. Device: SMES immediately after the ABX intravenous infusion began, the patient was placed in a supine position, the skin was routinely disinfected with 75% ethanol, and a stainless steel needle was inserted into GV20 and GV26.Then, the needles are stimulated by using an acupuncture point nerve stimulator with a frequency of 2/100 Hz and an intensity of 3 mA for 40 min (a homemade relay cycled power to the electrode for 6 sec on and 6 sec off). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMES+PTX | Other | This intervention involves the combined use of medication and device, where the specific mode electroacupuncture stimulation (SMES) intervention is administered simultaneously with the intravenous infusion of paclitaxel. |
| Measure | Description | Time Frame |
|---|---|---|
| 4-month progression-free survival rate | Comprehensive neurological examinations and MRI scans were performed at baseline to establish the initial disease status. These assessments were repeated at specified post-treatment time points (weeks 3, 6, 9, 12, 15, and 18) to evaluate changes compared to baseline. Responses, including complete response , partial response, stable disease , and progressive disease, were assessed according to the specific criteria outlined in the RANO 2.0 guidelines.Finally, the proportion of subjects in the intent-to-treat population with progression-free survival exceeding 4 months was calculated. | baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18. |
| Measure | Description | Time Frame |
|---|---|---|
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 | The questionnaire consists of 30 items and covers multiple dimensions, such as physical function, role function, emotional function, social function, quality of life, fatigue, pain, and other cancer-related symptoms. | baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18. |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xianming Lin PHD | Contact | +86-13858028101 | linxianming1966@163.com | |
| Zhaoxing Jia, PHD | Contact | +86-18356130598 | zhenxinzhenyi183@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Zhejiang Chinese Medical University | Recruiting | China | Hangzhou City, Zhejiang Province | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7636549 | Background | Chamberlain MC, Kormanik P. Salvage chemotherapy with paclitaxel for recurrent primary brain tumors. J Clin Oncol. 1995 Aug;13(8):2066-71. doi: 10.1200/JCO.1995.13.8.2066. | |
| 11180089 | Background | Chang SM, Kuhn JG, Robins HI, Schold SC Jr, Spence AM, Berger MS, Mehta M, Pollack IF, Rankin C, Prados MD. A Phase II study of paclitaxel in patients with recurrent malignant glioma using different doses depending upon the concomitant use of anticonvulsants: a North American Brain Tumor Consortium report. Cancer. 2001 Jan 15;91(2):417-22. doi: 10.1002/1097-0142(20010115)91:23.0.co;2-9. |
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The data and results of this study need to be confirmed by Lin Xianming
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| Paclitaxel | Drug | Paclitaxel is administered intravenously at a dose of 135-175mg/m², repeated every 3 weeks. |
|
| Specific mode electroacupuncture stimulation | Device | Patients assume a supine position. After routine skin disinfection with 75% ethanol, a stainless steel needle (size 0.25mm×40mm) is inserted into GV20 (Baihui), and another stainless steel needle (size 0.25mm×25mm, as described above) is inserted into GV26 (Shuigou). The acupoints are manually stimulated until the patient experiences soreness, distension, or heaviness (the "De Qi" response). Subsequently, the needles are stimulated using an acupuncture point nerve stimulator (HANS-200, Nanjing Jinsheng Ltd., China) at a frequency of 2/100 Hz and an intensity of 3 mA for 40 minutes (a homemade relay cycled power supply to the electrode, with 6 seconds on and 6 seconds off). The intervention is administered every three weeks, concurrently with paclitaxel treatment |
|
| The Neurological Assessment for Neuro-Oncology (NANO) | NANO Scale quantitatively assesses nine neurological functions in patients, including gait, muscle strength, sensation, visual fields, facial strength, speech, cognition, and limb coordination, with each category scored between 0 to 3 or 0 to 2. | baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18. |
| Overall survival(OS) | The time from enrollment to death for any reason (for lost-to-follow-up patients, the time of the last follow-up; for patients still alive at the end of the study, the time of the last follow-up). | On the last day of weeks 3, 6, 9, 12, 15, and 18 during the treatment period; and then monthly during the follow-up phase for a total of 12 times. |
| Disease control rate | Disease control rate refers to the proportion of patients in the intent-to-treat population who achieved complete response , partial response , or stable disease , as assessed by the RANO 2.0 criteria. | baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18. |
| Objective response rate | Objective response rate refers to the proportion of patients in the intent-to-treat population who achieved complete response or partial response , as assessed per the RANO 2.0 criteria. | baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18. |
| Progression-free survival | Progression-free survival was defined as the time interval from the initiation of SMES combined with ABX treatment until the first occurrence of any of the following events: radiographic disease progression as determined by Response Assessment in Neuro-Oncology (RANO) version 2.0 criteria, the development of intolerable treatment-related adverse events leading to treatment discontinuation, or death due to any cause. | On the last day of weeks 3, 6, 9, 12, 15, and 18 during the treatment period; and then monthly during the follow-up phase for a total of 12 times. |
| Duration of response | Duration of response was defined as the time interval between the first administration of SMES plus ABX therapy and the occurrence of disease progression. | baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18 |
| Duration of Disease Control | Duration of Disease Control was defined as the time interval from when a patient first achieved disease control (complete response , partial response , or stable disease until disease progression or death, whichever occurred first. | baseline and 1-2 days before the end of weeks 3, 6, 9, 12, 15, and 18 |
| Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 | Adverse reactions were recorded from the time of informed consent signing through the final visit, including any emerging symptoms, signs, and laboratory abnormalities. Common adverse reactions may include skin discomfort, pruritus, pain, etc., with severity graded into 5 levels. | On the 7th, 14th and 21st days of the 1st to 6th treatment cycles, each treatment cycle lasts for 21 days. |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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