Status:
UNKNOWN
Effect of Memantine on Radiotherapy-related Cognitive Impairment
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Cognitive Impairment
Eligibility:
All Genders
35-60 years
Phase:
PHASE2
PHASE3
Brief Summary
Purpose: This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the therapeutic effects of thalidomide in radiotherapy-related cognitive impairment. Further study details a...
Detailed Description
Application of radiotherapy to patients with head and neck cancer isa mainstay treatment in contemporaryoncology practice. However, patients who received radiation are vulnerable to development of cog...
Eligibility Criteria
Inclusion
- Patients must have received radiation therapy due to head and neck cancer.
- Prior irradiation is ≥1.5 yearsand≤ 6 years.
- Age\>/= 35 years but age\</=60.
- Estimated life expectancy must be greater than 12 months.
- Cognitive impairment exists for more than 4 weeks, withMMSE≤26, or MoCA≤25.
- Routine laboratory studies with bilirubin \</=1.0 \* upper limits of normal (ULN), aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT)\< 1.0 \* ULN, creatinine\<1.0 \* ULN, white-cell count \>/= 4,000 per cubic millimeter; neutrophils count \>/=1500 per cubic millimeter, platelets \>/= 100,000 per cubic millimeter; Hb\>/=110 gram per millilitres. PT, APTT, INR in a normal range.
- Constant caregivers who well understand and have willingness to sign a written informed consent document.
Exclusion
- evidence of tumor metastasis, recurrence, or invasion;
- evidence of very high intracranial pressure that suggests brain hernia and need surgery;
- previous treatment with memantine or other medications for cognitive impairment;
- history of mental disordersor cognitive impairment before radiotherapy;
- history of stroke, or high risk of vascular dementia;
- family history ofalzheimer's disease, pick's disease, etc.;
- history of severe head trauma;
- clinically significant active disease, e.g. New York Heart Association Grade II or greater congestive heart failure, serious and inadequately controlled cardiac arrhythmia, significant vascular disease, severe infection;
- history of allergy to relevant drugs;
- pregnancy, lactation, or fertility program in the following 12 months;
- participation in other experimental studies.
Key Trial Info
Start Date :
December 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03342443
Start Date
December 6 2017
End Date
December 1 2024
Last Update
April 12 2019
Active Locations (1)
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1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510120