Treatment of Cerebral Radiation Necrosis With GM1, a Prospective Study

Fudan University

Status: Unknown

Conditions: MRI; Cerebral Radiation Necrosis; Nasopharyngeal Carcinoma; Radiotherapy

Treatments: Drug: GM1

Study type: Observational

Funder types: Other

Identifiers

NCT01884987

CRN2013

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 monosialotetrahexosylganglioside (GM1)to treat CRN, and found that GM1 can successfully reverse CRN. So we carried out this prospective study to test the efficacy of GM1 for CRN.

Enrollment: 30 estimated 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. ② CRN combined with other cerebrovascular disease. ③CRN combined with the second primary malignancy. ④ CRN without neurologic symptoms or signs. ⑤ CRN combined with diabetes. ⑥CRN patients that were supposed to live less than 6 months.

Trial design

30 participants in 1 patient group

group one will receive non-GM1 conservative therapy

Description:

Group one will receive conservative therapy such as hyperbaric therapy or corticosteroids therapy or "wait and see" policy

Treatment:

Drug: GM1