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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02032147
Enrollment
30
Registered
2014-01-09
Start date
2009-03-31
Completion date
2012-10-31
Last updated
2014-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Necrosis, Nashopharyngeal Cancer, Nerve Growth Factor

Brief 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.

Interventions

DRUGNGF group

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

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
efficacy of using NGF for treating CRN6-8 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026