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A Study of Amifostine for Prevention of Facial Numbness in Radiosurgery Treatment of Trigeminal Neuralgia
This study has been terminated.
(Patterns of practice changed and this technique is no longer used.)
Sponsor:
Stanford University
Information provided by (Responsible Party):
Scott Soltys, Stanford University
ClinicalTrials.gov Identifier:
NCT01364259
First received: May 26, 2011
Last updated: February 16, 2017
Last verified: February 2017
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Trigeminal Neuralgia | Drug: Amifostine Procedure: CyberKnife stereotactic radiosurgery | Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Scott Soltys, Stanford University:
Primary Outcome Measures:
- 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:
- 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)
| Enrollment: | 17 |
| Study Start Date: | September 2008 |
| Study Completion Date: | January 2015 |
| Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01364259
Please refer to this study by its ClinicalTrials.gov identifier: 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
| 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 ) |
| Study First Received: | May 26, 2011 |
| Results First Received: | December 16, 2016 |
| Last Updated: | February 16, 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 |
ClinicalTrials.gov processed this record on September 21, 2017