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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Cerebral Necrosis Nashopharyngeal Cancer Nerve Growth Factor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NGF group

This group will be treated with NGF 18u daily for 60 days.

NGF group

Intervention Type DRUG

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

control group

this group will receive conservative therapy such as hyperbaric therapy or corticosteroids therapy or "wait and see" policy

No interventions assigned to this group

Interventions

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NGF group

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No