Treatment of Cerebral Radiation Necrosis With GM1, a Prospective Study

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

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-12-31

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 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.

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Detailed Description

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Conditions

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Radiotherapy Nasopharyngeal Carcinoma Cerebral Radiation Necrosis MRI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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group one will receive non-GM1 conservative therapy

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

GM1

Intervention Type DRUG

This group will be treated with GM1 80mg daily for 14 days, and then followed with GM1 40mg daily for 46 days.

Interventions

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GM1

This group will be treated with GM1 80mg daily for 14 days, and then followed with GM1 40mg daily for 46 days.

Intervention Type DRUG

Other Intervention Names

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monosialotetrahexosylganglioside

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. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No