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

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.

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Key information

Conditions

Cerebral Necrosis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Sensory and Autonomic Neuropathies Heredodegenerative Disorders, Nervous System Nashopharyngeal Cancer Nerve Growth Factor Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Cancer Center, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NGF group

Drug

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

Primary outcomes

efficacy of using NGF for treating CRN

Time frame: 6-8 months

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Jan 9, 2014
Registry last updated: Jan 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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