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

NCT ID: NCT01364259

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2015-01-31

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.

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.

Conditions

Trigeminal Neuralgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Placebo

Placebo and SRS

Group Type: PLACEBO_COMPARATOR

CyberKnife stereotactic radiosurgery

Intervention Type: PROCEDURE

CyberKnife stereotactic radiosurgery

Amifostine

Amifostine and CyberKnife stereotactic radiosurgery

Group Type: EXPERIMENTAL

Amifostine

Intervention Type: DRUG

Amifostine and CyberKnife stereotactic radiosurgery

Interventions

Amifostine

Amifostine and CyberKnife stereotactic radiosurgery

Intervention Type: DRUG

CyberKnife stereotactic radiosurgery

CyberKnife stereotactic radiosurgery

Intervention Type: PROCEDURE

Other Intervention Names

CyberKnife stereotactic radiosurgery

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Scott Soltys

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Clara Choi

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Scott Soltys

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

SU-05252011-7806

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-14896

Identifier Type: -

Identifier Source: org_study_id