Specific Model Electroacupuncture Stimulation Promotes Paclitaxel Delivery Across the BBB for Postoperative Glioma Patients: A Randomized Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Histologically confirmed high-grade glioma, with standard radiotherapy and chemotherapy post-surgical resection deemed unsuccessful, and recurrence confirmed by imaging.

• Age ≥18 and ≤70 years, open to all genders.

• 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.

• A Karnofsky Performance Score (KPS) ≥70 or a World Health Organization (WHO) performance status of ≤2.

• Meets the criteria for acupuncture, with no severe complications, able to undergo acupuncture treatment and demonstrates good compliance.

• Clear consciousness, with the ability to perceive and distinguish pain, and capable of basic communication.

• Signed informed consent, voluntarily participating in this study.

Locations
Other Locations
China
The Third Affiliated Hospital of Zhejiang Chinese Medical University
RECRUITING
Zhejiang
Contact Information
Primary
Xianming Lin, PHD
linxianming1966@163.com
+86-13858028101
Backup
Zhaoxing Jia, PHD
zhenxinzhenyi183@163.com
+86-18356130598
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 58
Treatments
Other: TMZ group
Temozolomide(TMZ) was given orally or intravenously 150mg/(m2·d) for 5 days, repeated every 28 days for 6 cycles
Other: SMES+ABX+TMZ Group
Drug:~Oral or intravenous infusion of TMZ 150mg/(m2·d) for 5 days, repeated after 23 days of suspension, a total of 6 treatment cycles. During the TMZ treatment cycle, specific mode electroacupuncture stimulation(SMES) combined with Paclitaxel for Injection (Albumin Bound)(ABX) were used on day 1 and day 8.~ABX: ABX was prepared with 0.9% sodium chloride injection and the dosage required by the patient was calculated at 110mg/mm2. Then the intravenous infusion continues for 30 minutes.~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).
Related Therapeutic Areas
Sponsors
Collaborators: Zhejiang University
Leads: The Third Affiliated hospital of Zhejiang Chinese Medical University

This content was sourced from clinicaltrials.gov