Treatment of Cerebral Radiation Necrosis (CRN) With Nerve Growth Factor (NGF)

Cerebral Necrosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02032147
• Other study ID #: CRN2009
• Status: Completed
• Phase: N/A
• First received: September 27, 2013
• Last updated: January 8, 2014
• Start date: March 2009
• Est. completion date: October 2012

Study information

• Verified date: January 2014
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Observational

Clinical Trial Summary

Cerebral radiation necrosis (CRN) is a well-documented late complication of radiation therapy for cancers, and may have a devastating effect on the patient's quality of life (QOL). However,CRN was once regarded as a progressive and irreversible disease, no standard therapy has been suggested for CRN. In our clinical practice, we have used nerve growth factor(NGF) to treat CRN, and found that GM1 can successfully reverse CRN. A case report has been published in Journal of Clinical Oncology (JCO) in 2011. So we carried out this prospective study to test the efficacy of NGF for CRN.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• The necrotic mass shown on MRI must be measured in two dimensions. No local or regional recurrence, no distant metastasis. Karnofsky performance status of at least 70 and were supposed to live more than 6 months.

Exclusion Criteria:

• CRN combined with local or regional relapse, or with distant metastasis.

• CRN combined with other cerebrovascular disease.

• CRN combined with the second primary malignancy.

• CRN without neurologic symptoms or signs.

• CRN combined with diabetes.

• CRN patients that were supposed to live less than 6 months.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Necrosis
• Nashopharyngeal Cancer
• Necrosis
• Nerve Growth Factor

Intervention

Drug:
• NGF group
This group will be treated with NGF 18u per day im for 60 days

Locations

Country	Name	City	State
China	Shanghai Cancer Center, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of using NGF for treating CRN		6-8 months	No