Actively Recruiting
Effect of Electroacupuncture Combined With Paclitaxel Clinical Efficacy of Patients With Recurrence of High-grade Glioma
Led by The Third Affiliated hospital of Zhejiang Chinese Medical University · Updated on 2024-03-26
58
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
Sponsors
T
The Third Affiliated hospital of Zhejiang Chinese Medical University
Lead Sponsor
Z
Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Electroacupuncture Combined With Paclitaxel Clinical Efficacy of Patients With Recurrence of High-grade Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed high-grade glioma with recurrence after surgery and standard radiotherapy and chemotherapy
- Age between 18 and 70 years
- Stable or decreasing dexamethasone dose less than 6 mg daily if used for mass effect
- Karnofsky Performance Score of 70 or higher or WHO performance status of 2 or less
- Suitable for acupuncture with no severe complications and good compliance
- Clear consciousness and ability to communicate
- Signed informed consent and voluntary participation
You will not qualify if you...
- Uncontrolled epileptic seizures
- Peripheral neuropathy greater than Grade 1
- Participation in another clinical trial within the last 3 months
- Previous treatment with paclitaxel or similar agents, or allergy to these drugs
- Severe heart, liver, kidney, or blood dysfunction as defined by specific lab criteria within 14 days before treatment
- Pregnant or breastfeeding women
- Cognitive impairment, history of substance abuse
- History of fainting with needles or acupuncture site infections
- Presence of conductive foreign bodies in the body
- Unable to undergo enhanced MRI examinations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Zhejiang, China
Actively Recruiting
Research Team
X
Xianming Lin, PHD
CONTACT
Z
Zhaoxing Jia, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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