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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Trigeminal Neuralgia	Drug: Amifostine; Procedure: CyberKnife stereotactic radiosurgery	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	17 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	A Randomized, Placebo-controlled Trial of Amifostine for Prevention of Facial Numbness in Patients Receiving Stereotactic Radiosurgery for Trigeminal Neuralgia
Study Start Date :	September 2008
Actual Primary Completion Date :	January 2014
Actual Study Completion Date :	January 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: CyberKnife stereotactic radiosurgery

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Pain Relief Following Radiosurgery [ Time Frame: 1 year ]
   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)

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator:	Clara Choi	Stanford University
Principal Investigator:	Scott Soltys	Stanford University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Scott Soltys, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier:	NCT01364259 History of Changes
Other Study ID Numbers:	IRB-14896; SU-05252011-7806 ( Other Identifier: Stanford alternate number )
First Posted:	June 2, 2011
Results First Posted:	April 4, 2017
Last Update Posted:	April 4, 2017
Last Verified:	February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Scott Soltys, Stanford University:

tic douloureux

Additional relevant MeSH terms:

Neuralgia; Trigeminal Neuralgia; Pain; Neurologic Manifestations; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Signs and Symptoms; Trigeminal Nerve Diseases	Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Amifostine; Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs