Clinical trial · Interventional
Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
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
NCT07116811CI-TRIAL-00093498SAF-NRVSnot yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Facial Nerve Paralysis | — | UNRESOLVED | — |
| Vestibular Schwannoma | Vestibular Schwannoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Steroids therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Steroids Group
- description
- Methylprednisolone sodium succinate (80 mg/day) on days 1-3 post-surgery, followed by prednisone acetate (20 mg/day) on days 4-10.
- interventionNames
- Drug: Steroids therapy
- type
- PLACEBO_COMPARATOR
- label
- Placebo Group
- description
- Methylprednisolone sodium succinate placebo on days 1-3 post-surgery, followed by prednisone acetate placebo on days 4-10.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Good facial nerve function (House-Brackmann grade I or II) at 90 days after surgery
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 18 and 60 years 2. Diagnosed with untreated unilateral vestibular schwannoma 3. No facial palsy before surgery (House-Brackmann grade I) 4. 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 5. Signed informed consent Exclusion Criteria: 1. Contraindications for craniotomy 2. Patients requiring corticosteroids during the perioperative period, or with known corticosteroid contraindications 3. Patients or first-degree relatives with a confirmed diagnosis of neurofibromatosis type 2 (NF2) 4. Karnofsky Performance Status (KPS) score \<90 before disease onset 5. Pregnant or planning to become pregnant during the study period 6. Participation in other interventional clinical trials 7. Judged unsuitable by the investigators
References
Publications (0)
Data not yet available
No reference posted for this study.