The Effect of Steroids Treatment for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients (SAF-NRVS): a Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 364
- 试验地点
- 1
- 主要终点
- Good facial nerve function (House-Brackmann grade I or II) at 90 days after surgery
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of steroids treatment compared with placebo in preserving facial nerve function after craniotomy in patients with vestibular schwannoma who have not received preoperative treatment and have good intraoperative facial nerve function.
详细描述
Vestibular schwannoma (VS) is a benign tumor arising from the vestibular nerve. Surgical resection is a common treatment, and intraoperative neurophysiological monitoring (IONM) is widely used to protect facial nerve function. However, postoperative facial nerve paralysis remains a common complication, affecting patients' appearance, confidence, and quality of life.
Steroids are often used to reduce inflammation and edema in idiopathic facial palsy, but their efficacy and safety in post-surgical VS patients remain uncertain. The mechanism of post-surgical facial nerve dysfunction is more complex than idiopathic palsy and may involve physical traction, vascular compromise, or inflammatory injury.
This study (SAF-NRVS) is a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. Patients aged 18 to 60 years with a clinically confirmed untreated unilateral vestibular schwannoma will be enrolled. Eligible patients must have no preoperative facial paralysis (grade I according to the House-Brackmann grading system), and have good intraoperative facial nerve function as determined by intraoperative neurophysiological monitoring. Participants will be randomly divided into two groups in a 1:1 ratio. Intervention group (Steroids group) will receive 80 mg of methylprednisolone sodium succinate powder dissolved in 100 ml of sodium chloride (NaCl) solution by intravenous infusion once daily from the day of surgery to day 3, followed by 20 mg of prednisone acetate oral intake once daily from day 4 to day 10. Control group (Placebo group) will receive methylprednisolone sodium succinate placebo powder dissolved in 100 ml of NaCl solution by intravenous infusion once daily from the day of surgery to day 3, followed by prednisone acetate placebo oral intake once daily from day 4 to day 10. The primary outcome measure is the proportion of patients with good facial nerve function recovery at 90 days after surgery, defined as grade 1 or 2 according to House-Brackmann grading system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study adopted a double-blind design. Study drugs and placebos are identically packaged. The dosage form, size, color, weight, smell, and taste of the placebo were basically similar to those of the research drug, and there was no risk of blinding. Personnel involved in randomization or potentially exposed to treatment allocation (including pharmacy staff) are not involved in patient care, outcome assessment, or data analysis. Blinded investigators and outcome assessors remain unaware of treatment assignments throughout the study.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 60 years
- •Diagnosed with untreated unilateral vestibular schwannoma
- •No facial palsy before surgery (House-Brackmann grade I)
- •Intraoperative neurophysiological monitoring confirms good facial nerve function preservation, defined as: a）Post-tumor resection, evoked compound muscle action potential amplitude >420 μV under 0.05 mA stimulation；and b）The amplitude is >60% of baseline value measured before dural opening
- •Signed informed consent
排除标准
- •Contraindications for craniotomy
- •Patients requiring corticosteroids during the perioperative period, or with known corticosteroid contraindications
- •Patients or first-degree relatives with a confirmed diagnosis of neurofibromatosis type 2 (NF2)
- •Karnofsky Performance Status (KPS) score <90 before disease onset
- •Pregnant or planning to become pregnant during the study period
- •Participation in other interventional clinical trials
- •Judged unsuitable by the investigators
研究组 & 干预措施
Steroids Group
Methylprednisolone sodium succinate (80 mg/day) on days 1-3 post-surgery, followed by prednisone acetate (20 mg/day) on days 4-10.
干预措施: Steroids therapy (Drug)
Placebo Group
Methylprednisolone sodium succinate placebo on days 1-3 post-surgery, followed by prednisone acetate placebo on days 4-10.
干预措施: Placebo (Drug)
结局指标
主要结局
Good facial nerve function (House-Brackmann grade I or II) at 90 days after surgery
时间窗: at 90 (±7) days after surgery
Defined as House-Brackmann grade I or II.
次要结局
- Complete facial nerve function recovery (House-Brackmann grade I) at 90 days after surgery(at 90 (±7) days after surgery)
- Serious adverse events within 10 days(Within 10 days after surgery)
- Good facial nerve function (House-Brackmann grade I or II) at 10 days after surgery(at 10 days after surgery)
- Serious adverse events within 90 days(Within 90 (±7) days after surgery)
- Complete facial nerve function recovery (House-Brackmann grade I) at 10 days after surgery(at 10 days after surgery)
- Complete facial nerve function recovery (Sunnybrook scale 100 score) at 90 days after surgery(at 90 (±7) days after surgery)
- Adverse events within 90 days(Within 90 (±7) days after surgery)
- Complete facial nerve function recovery (Sunnybrook scale 100 score) at 10 days after surgery(at 10 days after surgery)
- Adverse events within 10 days(Within 10 days after surgery)
研究者
Wang Jia
Professor of Beijing Tiantan Hospital, Capital Medical University
Beijing Tiantan Hospital