Anti-mycobacterium treatment reverses cerebral radiation necrosis

Not Applicable

Completed

• Conditions: Delayed brain radiation injury/temporal lobe necrosis/oncology; Cancer; Radiation

• Registration Number: ISRCTN04023349
• Lead Sponsor: Sun Yat-sen University (China)

Brief Summary

1. 2014 results in http://dx.doi.org/10.11648/j.jctr.20140205.12 (added 22/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-18
• Study Completion: 2014-12-30
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients who fulfilled the following eligibility criteria were recruited in this study:
1. Aged 18 to 65 years
2. Histopathologically proven cases of NPC who had undergone radiation therapy, with
negative brain MR before RT
3. Patients must have received cranial irradiation = 6 months prior to study entry
4. MRI evidence of bilateral temporal lobe edema and/or necrosis with
or without foci of contrast enhancement on MRI
5. Evidence of progressive neurologic signs or symptoms related with TLN

Exclusion Criteria

Patients were excluded if they had:
1. Significant hepatic or renal insufficiency
2. Evidence of brain metastasis, brain abscess, any intracranial tumor, cerebral infarction,
demyelinating disease
3. Clinical manifestations such as fever, meningeal irritatation signs indicating meningitis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Activities of daily living (ADL) were adopted to assess subjects? neurological status. ADL were assessed by the Barthel Index (BI) (0?100 scale, with lower scores denoting less independence in activities of daily living)

Secondary Outcome Measures

Name	Time	Method
Evaluation by MRI tests