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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

May 26, 2011
June 2, 2011
December 16, 2016
April 4, 2017
April 4, 2017
September 2008
January 2014   (Final data collection date for primary outcome measure)
Facial Numbness Following Radiosurgery [ Time Frame: 1 year ]
Percent of patients with facial numbness following radiosurgery will be determined at one year follow up.
Facial Numbness Following Radiosurgery [ Time Frame: 1 year ]
Percent of patients with facial numbness following radiosurgery will be determined.
Complete list of historical versions of study NCT01364259 on ClinicalTrials.gov Archive Site
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)
Pain Relief Following Radiosurgery [ Time Frame: 6 months ]
Pain score following radiosurgery will be measured. Latency to pain relief will be assessed.
Not Provided
Not Provided
 
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.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Trigeminal Neuralgia
  • Drug: Amifostine
    Amifostine and CyberKnife stereotactic radiosurgery
    Other Name: CyberKnife stereotactic radiosurgery
  • Procedure: CyberKnife stereotactic radiosurgery
    CyberKnife stereotactic radiosurgery
  • Placebo Comparator: Placebo
    Placebo and SRS
    Intervention: Procedure: CyberKnife stereotactic radiosurgery
  • Experimental: Amifostine
    Amifostine and CyberKnife stereotactic radiosurgery
    Intervention: Drug: Amifostine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
17
January 2015
January 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01364259
IRB-14896
SU-05252011-7806 ( Other Identifier: Stanford alternate number )
Yes
Not Provided
Plan to Share IPD: No
Scott Soltys, Stanford University
Stanford University
Not Provided
Principal Investigator: Clara Choi Stanford University
Principal Investigator: Scott Soltys Stanford University
Stanford University
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP