Treatment of Cerebral Radiation Necrosis With GM1, a Prospective Study

NCT01884987 | Unknown

• 1 other identifier: CRN2013
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Radiotherapy; Nasopharyngeal Carcinoma; Cerebral Radiation Necrosis; MRI

Outcome Measures

Primary Outcomes (1)

• The necrotic volume showed on MRI

  6-8 months

Secondary Outcomes (1)

• relief of the symptoms related to CRN

  6-8 months

Study Arms (1)

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

Drug: GM1

Interventions

GM1 DRUG

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

Also known as: monosialotetrahexosylganglioside

group one will receive non-GM1 conservative therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients must have undergone definitive RT for histologically confirmed NPC years before. They were required to have at least two consecutive magnetic resonance imaging (MRI) study supporting the diagnosis of CRN with an interval of 3-4 months, with the second MRI showing progressive disease compared with the first MRI. The necrotic mass shown on MRI must be measured in two dimensions in order to define the response to treatment. Other radiologic studies were also required to support the non-existence of local or regional recurrence, distant metastasis. Patients must have undergone mental status examinations and had progressive neurologic symptoms or signs. In addition, they were required to have a Karnofsky performance status of at least 70 and were supposed to live more than 6 months.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Shanghai Cancer Center, Fudan University

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

G(M1) Ganglioside

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Gangliosides; Acidic Glycosphingolipids; Glycosphingolipids; Glycolipids; Glycoconjugates; Carbohydrates; Lipids; Sphingolipids; Membrane Lipids

Study Officials

• ChaoSu Hu, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ChaoSu Hu, MD, PhD

CONTACT

86-21-64175590; hucsu62@126.com

XiaoShen Wang, MD, PhD

CONTACT

86-21-64175590; ruijin702@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 19, 2013
• First Posted: June 24, 2013
• Study Start: January 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 7, 2014

Record last verified: 2014-01

Locations

CN (1)