Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02032147
Recruitment Status : Completed
First Posted : January 9, 2014
Last Update Posted : January 9, 2014
Sponsor:
Information provided by (Responsible Party):
Fan Ming, Fudan University

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 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.

Condition or disease Intervention/treatment
Cerebral Necrosis Nashopharyngeal Cancer Nerve Growth Factor Drug: NGF group

Layout table for study information
Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : March 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Group/Cohort Intervention/treatment
NGF group
This group will be treated with NGF 18u daily for 60 days.
Drug: NGF group
This group will be treated with NGF 18u per day im for 60 days

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



Primary Outcome Measures :
  1. efficacy of using NGF for treating CRN [ Time Frame: 6-8 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032147


Locations
Layout table for location information
China, Shanghai
Shanghai Cancer Center, Fudan University
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University

Layout table for additonal information
Responsible Party: Fan Ming, MD,PhD, Fudan University
ClinicalTrials.gov Identifier: NCT02032147     History of Changes
Other Study ID Numbers: CRN2009
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Necrosis
Pathologic Processes