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

Fudan University

Status: Completed

Conditions: Cerebral Necrosis; Nashopharyngeal Cancer; Nerve Growth Factor

Treatments: Drug: NGF group

Study type: Observational

Funder types: Other

Identifiers

NCT02032147

CRN2009

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 2 patient groups

NGF group

Description:

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

Treatment:

Drug: NGF group

control group

Description:

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