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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:
ClinicalTrials.gov Identifier:
NCT01364259
First Posted: June 2, 2011
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Scott Soltys, Stanford University
Results First Submitted: December 16, 2016  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patient’s pretreatment pain, neurologic function (including facial numbness), and health related quality of life will be assessed.

Reporting Groups
  Description
Placebo

Placebo and SRS

CyberKnife stereotactic radiosurgery (srs)

Amifostine

Amifostine and SRS

CyberKnife stereotactic radiosurgery and Amifostine


Participant Flow:   Overall Study
    Placebo   Amifostine
STARTED   9   8 
COMPLETED   9   8 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo

Placebo and SRS

CyberKnife stereotactic radiosurgery + saline

Amifostine

Amifostine and CyberKnife stereotactic radiosurgery

CyberKnife stereotactic radiosurgery + amofostine

Total Total of all reporting groups

Baseline Measures
   Placebo   Amifostine   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   8   17 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female      5  55.6%      7  87.5%      12  70.6% 
Male      4  44.4%      1  12.5%      5  29.4% 
Region of Enrollment 
[Units: Participants]
     
United States   9   8   17 


  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Pain Relief Following Radiosurgery   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: sgsoltys@stanford.edu



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