A Study of Amifostine for Prevention of Facial Numbness in Radiosurgery Treatment of Trigeminal Neuralgia

A Randomized, Placebo-controlled Trial of Amifostine for Prevention of Facial Numbness in Patients Receiving Stereotactic Radiosurgery for Trigeminal Neuralgia

Trigeminal neuralgia or tic douloureux is severe, often debilitating, facial pain that significantly impairs the patient's quality of life and health. Stereotactic radiosurgery has been shown to provide pain relief in majority of patients treated. However, a common side effect of radiosurgery is facial numbness. Our goal is to maximize pain control while minimizing side effects. To this end, the purpose of this study is to evaluate whether adding a drug, amifostine, at the time of radiosurgery will protect patients from facial numbness.

Study Overview

• Status: Terminated
• Conditions: Trigeminal Neuralgia
• Intervention / Treatment: Procedure: CyberKnife stereotactic radiosurgery; Drug: Amifostine

Detailed Description

Patients will be evaluated by a multi-disciplinary team composed of radiation oncologists and neurosurgeons. Pretreatment pain, neurologic function (including facial numbness), and health related quality of life will be assessed. Patients will be treated in a single session with 75 Gy maximal dose covering a 6 mm segment of the retrogasserian cisternal portion of the trigeminal sensory root. Treatment will be delivered using the CyberKnife Robotic Radiosurgery System with the patient in the supine position. An aquaplast head mask will be used to ensure adequate immobilization during therapy. The target volume shall be the 6 mm segment of the retrogasserian cisternal portion of the trigeminal sensory root. Patients will receive subcutaneous injection of amifostine (500 mg) or placebo 30 minutes +/- 30 minutes prior to SRS. Facial pain will be assessed using the Visual Analog Scale and Short-form McGill Pain Questionnaire. Following SRS, patients will be followed at 1, 3, 6, and 9 months ±7 days. Facial numbness will be assessed using the Barrow Neurologic Institute (BNI) Facial Numbness Score. Patient reported BNI facial numbness scoring and complete cranial nerve exam by a physician will be performed pre-treatment and at follow-up visits.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All patients age 18 years and older with typical trigeminal neuralgia, as determined by diagnostic criteria set by the International Headache Society, who are:

• Intolerant of or refractory to medical management; AND
• Not candidates for or refusing a surgical micro-vascular decompression.

Exclusion Criteria:

• Patients who present with pre-existing BNI grade III or IV facial numbness.
• Patients who have previously been treated with MVD.
• Patients who have previously had an ablative treatment, including prior SRS.
• Pediatric patients (age <18), pregnant women, and patients who are unable to give informed consent will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo and SRS	Procedure: CyberKnife stereotactic radiosurgery; CyberKnife stereotactic radiosurgery
Experimental: Amifostine; Amifostine and CyberKnife stereotactic radiosurgery	Drug: Amifostine; Amifostine and CyberKnife stereotactic radiosurgery; Other Names: CyberKnife stereotactic radiosurgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facial Numbness Following Radiosurgery	Percent of patients with facial numbness following radiosurgery will be determined at one year follow up.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Relief Following Radiosurgery	Pain improvement as assessed by the Barrow Neurological Institute (BNI) facial pain score from pre-treatment baseline of BNI 3-5 (3-some pain/controlled on medications, 4-some pain/not controlled on medications, 5-severe pain) to BNI 1-2 (1-no pain/ no medication, 2- occasional pain/no medication)	1 year

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: May 26, 2011
• First Submitted That Met QC Criteria: June 1, 2011
• First Posted (Estimate): June 2, 2011

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: tic douloureux
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Neuralgia; Trigeminal Neuralgia; Physiological Effects of Drugs; Protective Agents; Radiation-Protective Agents; Amifostine
• Other Study ID Numbers: IRB-14896; SU-05252011-7806 (Other Identifier: Stanford alternate number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No