Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Steroids therapy
DrugMethylprednisolone sodium succinate 80 mg powder dissolved in 100 mL of sodium chloride solution (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.
Placebo
DrugMethylprednisolone sodium succinate placebo powder dissolved in 100 mL of sodium chloride solution (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.
Treatment groups
364 Participants
are divided into 2 treatment groupsGroup A: Steroids GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Good facial nerve function (House-Brackmann grade I or II) at 90 days after surgery
Defined as House-Brackmann grade I or II.
Time frame
at 90 (±7) days after surgerySecondary outcomes
1
Good facial nerve function (House-Brackmann grade I or II) at 10 days after surgery
Defined as House-Brackmann grade I or II.
Time frame
at 10 days after surgery2
Complete facial nerve function recovery (House-Brackmann grade I) at 90 days after surgery
Defined as House-Brackmann grade I
Time frame
at 90 (±7) days after surgery3
Complete facial nerve function recovery (House-Brackmann grade I) at 10 days after surgery
Defined as House-Brackmann grade I
Time frame
at 10 days after surgery4
Complete facial nerve function recovery (Sunnybrook scale 100 score) at 90 days after surgery
Sunnybrook Facial Grading System will be used. Score of 100 represents complete recovery.
Time frame
at 90 (±7) days after surgerySponsors and contacts
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Source ClinicalTrials.gov
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