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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Trigeminal Neuralgia
Interventions Drug: Amifostine
Procedure: CyberKnife stereotactic radiosurgery
Enrollment 17
Recruitment Details Patients will be evaluated by a multi-disciplinary team composed of radiation oncologists and neurosurgeons. During their visit, a physician or research coordinator will explain the study. Patients will be given the informed consent form to read. If they agree to participate, they will be asked to sign the consent form prior to participating.
Pre-assignment Details Patient’s pretreatment pain, neurologic function (including facial numbness), and health related quality of life will be assessed.
Arm/Group Title Placebo Amifostine
Hide Arm/Group Description

Placebo and SRS

CyberKnife stereotactic radiosurgery (srs)

Amifostine and SRS

CyberKnife stereotactic radiosurgery and Amifostine

Period Title: Overall Study
Started 9 8
Completed 9 8
Not Completed 0 0
Arm/Group Title Placebo Amifostine Total
Hide Arm/Group Description

Placebo and SRS

CyberKnife stereotactic radiosurgery + saline

Amifostine and CyberKnife stereotactic radiosurgery

CyberKnife stereotactic radiosurgery + amofostine

Total of all reporting groups
Overall Number of Baseline Participants 9 8 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 8 participants 17 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  11.1%
1
  12.5%
2
  11.8%
>=65 years
8
  88.9%
7
  87.5%
15
  88.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 8 participants 17 participants
Female
5
  55.6%
7
  87.5%
12
  70.6%
Male
4
  44.4%
1
  12.5%
5
  29.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 8 participants 17 participants
9 8 17
1.Primary Outcome
Title Facial Numbness Following Radiosurgery
Hide Description Percent of patients with facial numbness following radiosurgery will be determined at one year follow up.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject randomized to drug arm did not have data.
Arm/Group Title Placebo Amifostine
Hide Arm/Group Description:

Placebo and SRS

CyberKnife stereotactic radiosurgery (srs)

Amifostine and SRS

CyberKnife stereotactic radiosurgery and Amifostine

Overall Number of Participants Analyzed 9 7
Measure Type: Count of Participants
Unit of Measure: Participants
7
  77.8%
6
  85.7%
2.Secondary Outcome
Title Pain Relief Following Radiosurgery
Hide Description 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)
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
8 subjects were enrolled on the Amifostine arm, however, one subject was enrolled but withdrew prior to treatment.
Arm/Group Title Placebo Amifostine
Hide Arm/Group Description:

Placebo and SRS

CyberKnife stereotactic radiosurgery (srs)

Amifostine and SRS

CyberKnife stereotactic radiosurgery and Amifostine

Overall Number of Participants Analyzed 9 7
Measure Type: Count of Participants
Unit of Measure: Participants
9
 100.0%
5
  71.4%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Amifostine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.175
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0
Estimation Comments Our odds ratio is equal to 0*5/9*2 because we have a zero cell in the two by two table. Hence the OR = 0.
Time Frame Data was collected for 9 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Amifostine
Hide Arm/Group Description

Placebo and SRS

CyberKnife stereotactic radiosurgery (srs)

Amifostine and SRS

CyberKnife stereotactic radiosurgery and Amifostine

All-Cause Mortality
Placebo Amifostine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Amifostine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Amifostine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/7 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Scott G. Soltys, Assistant Professor
Organization: Stanford University Cancer Center
Phone: 650.724.1569
Responsible Party: Scott Soltys, Stanford University
ClinicalTrials.gov Identifier: NCT01364259     History of Changes
Other Study ID Numbers: IRB-14896
SU-05252011-7806 ( Other Identifier: Stanford alternate number )
First Submitted: May 26, 2011
First Posted: June 2, 2011
Results First Submitted: December 16, 2016
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017