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

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ClinicalTrials.gov Identifier: NCT01364259
Recruitment Status : Terminated (Patterns of practice changed and this technique is no longer used.)
First Posted : June 2, 2011
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Scott Soltys, Stanford University

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

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Arms and Interventions
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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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364259


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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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    Key Record Dates
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