Cognitive Impairment Clinical Trial
Official title:
Effect of Memantine on Radiotherapy-related Cognitive Impairment
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 as provided by Sun Yat-sen Memorial Hospital, Sun Yat-sen University /
Yameitang.
Primary outcome measure: cognitive improvement, which is determined by the difference value
of ADAS-cog score before and after the treatment of memantine.
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 cognitive impairment.There is no acknowledged and effective standard treatment
for radiotherapy-related cognitive impairment. We supposed that memantine, as the
N-methyl-D-aspartate receptor antagonist, would relieve radiotherapy-related cognitive
impairment after head and neck cancer, and would improve the life quality for these patients
and their families.
Primary objectives: This randomized, double-blind, placebo-controlled clinical trial aims to
evaluate the efficacy of memantineon cognition in radiotherapy-related cognitive impairment.
Secondary objectives:
To evaluate the effect of memantine on sleep disorder, mood disorder, activities of daily
living, and safety in patients with radiotherapy-related cognitive impairment.
OUTLINE: This is randomized, double-blind, placebo-controlled clinical trial. Patients will
be enrolled and administrated with memantine or placebo. Memantine will be supplied as 10 mg
per pill to be taken by mouth. Placebo will be supplied as substitute of 10 mg memantine per
pill to be taken by mouth.
Patients will be screened, consented, enrolled and have a washout period for 6 weeks. Then
these patients will be randomized to two arms.
Arm І: Patients receive memantine with a dosage of 5 microgram at 8 am daily for one week
(Week 1), then 5 microgram at 8 am and5 microgram at 5 pm for one week (Week 2), then 10
microgram at 8 am and 5 microgram at 5 pm for one week (Week 3), then 10 microgram at 8 am
and 10 microgram at 5 pm for 21 weeks (Week 4-24), in the absence of unacceptable toxicity or
severe deterioration.
Arm ІI: Patients receive placebo with a dosage of one half pill at 8 am daily for one week
(Week 1), then one half pill at 8 am and one half pill at 5 pm for one week (Week 2), then
one pill at 8 am and one half pill at 5 pm for one week (Week 3), then one pill at 8 am and
one pill at 5 pm for 21 weeks (Week 4-24), in the absence of unacceptable toxicity or severe
deterioration.
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