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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized, Placebo-controlled Trial of Amifostine for Prevention of Facial Numbness in Patients Receiving Stereotactic Radiosurgery for Trigeminal Neuralgia

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 Summary: 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.
Sponsor: Stanford University

Current Primary Outcome: Facial Numbness Following Radiosurgery [ Time Frame: 1 year ]

Percent of patients with facial numbness following radiosurgery will be determined at one year follow up.


Original Primary Outcome: Facial Numbness Following Radiosurgery [ Time Frame: 1 year ]

Percent of patients with facial numbness following radiosurgery will be determined.


Current Secondary Outcome: 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)


Original Secondary Outcome: Pain Relief Following Radiosurgery [ Time Frame: 6 months ]

Pain score following radiosurgery will be measured. Latency to pain relief will be assessed.


Information By: Stanford University

Dates:
Date Received: May 26, 2011
Date Started: September 2008
Date Completion:
Last Updated: February 16, 2017
Last Verified: February 2017