Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis

University of Chinese Academy Sciences

Status and phase: Unknown; Phase 2

Conditions: Cerebral Radiation Necrosis

Treatments: Drug: Monosialoganglioside Ganglioside; Drug: Methylprednisolone (Steroid Hormone); Drug: Prednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT03067753

ZJCH-2016-HN02

Details and patient eligibility

About

Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis

Full description

A prospective phase II trial was conducted to test the efficacy of monosialoganglioside ganglioside for the treatment of cerebral radiation necrosis

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Undergone only one course of definitive radiotherapy for histologically confirmed nasopharyngeal carcinoma years before;
• At least two consecutive MRI study supporting the diagnosis of cerebral radiation necrosis(CRN) with an interval of 3-4 months, with the second MRI showing progressive disease compared with the first MRI;
• Progressive neurologic symptoms or signs;
• Mini-mental status examination(MMSE) score must be ≤27;
• Karnofsky performance status≥70 ;
• Supposed to live more than 6 months.

Exclusion criteria

• After the second course of radiotherapy for recurrent nasopharyngeal carcinoma;
• Local or regional relapse,or with distant metastasis;
• Cerebrovascular disease;
• Second primary malignancy;
• Diabetes.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Pulsed steroid

Active Comparator group

Description:

Pulse steroid, methylprednisolone, was administered by intravenous infusion over 3 consecutive days. Three grams of methylprednisolone was given in each cycle. Administration of 1 g was infused over 1 h daily for 3 days on an in-patient basis, which then tailed off in 10 days with administration of oral prednisolone.

Treatment:

Drug: Prednisolone

Drug: Methylprednisolone (Steroid Hormone)

Monosialoganglioside ganglioside

Experimental group

Description:

Monosialoganglioside ganglioside was given at 100 mg/time, once a day for 2 months.

Treatment:

Drug: Monosialoganglioside Ganglioside