Trial Title:
Effect of Electroacupuncture Combined With Paclitaxel Clinical Efficacy of Patients With Recurrence of High-grade Glioma
NCT ID:
NCT06330337
Condition:
Glioma
Conditions: Official terms:
Glioma
Paclitaxel
Temozolomide
Albumin-Bound Paclitaxel
Conditions: Keywords:
glioma
Specific Mode Electroacupuncture Stimulation
protein-bound paclitaxel
blood-brain barrier
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Temozolomide（TMZ） injection or oral administration
Description:
Oral administration of TMZ150-200mg/m2/ day, continuous use for 5 days, discontinued for
23 days, for a treatment cycle, a total of 6 cycles.
Arm group label:
SMES+ABX+TMZ Group
Arm group label:
TMZ group
Intervention type:
Drug
Intervention name:
Albumin-Bound Paclitaxel(ABX) intravenous drip
Description:
ABX was administered intravenously at a dose of 110mg/m2 on days 1 and 8 of a 28-day
treatment cycle
Arm group label:
SMES+ABX+TMZ Group
Intervention type:
Device
Intervention name:
Specific mode electroacupuncture stimulation(SMES) intervention
Description:
Patients take supine position. After skin disinfection with 75% ethanol routine
disinfection, the stainless needle (size 0.25mm×40mm, Hua Tuo brand, Suzhou Medical
Supplies Company Ltd in Jiangsu, China) will be inserted in GV20（Baihui) and the
stainless needle(size 0.25mm×25mm, described above) will be inserted in GV26 (Shuigou),
acupoints will be stimulated manually until patients feel soreness, distension or
heaviness (the reaction of "De Qi"). Then, the needles are stimulated by using an
acupuncture point nerve stimulator (HANS-200, Nanjing Jinsheng, Ltd., China) 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).The 28-day treatment cycle was followed by
simultaneous intervention with ABX on days 1 and 8.
Arm group label:
SMES+ABX+TMZ Group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Address:
City:
Zhejiang
Country:
China
Status:
Recruiting
Contact:
Last name:
Xianming Lin, PHD
Phone:
+86-13858028101
Email:
linxianming1966@163.com
Contact backup:
Last name:
Zhaoxing Jia, PHD
Phone:
+86-18356130598
Email:
zhenxinzhenyi183@163.com
Start date:
April 1, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
The Third Affiliated hospital of Zhejiang Chinese Medical University
Agency class:
Other
Collaborator:
Agency:
Zhejiang University
Agency class:
Other
Source:
The Third Affiliated hospital of Zhejiang Chinese Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06330337
