Phase II - Pilot Clinical Trial of COGNUTRIN in Breast Cancer Survivors
This is a randomized, double-blind pilot study of COGNUTRIN vs. Placebo.
Participants have an equal chance (like flipping a coin) of being in either of the study
groups. Neither the participant nor the study doctor will be able to choose which study
group the participant is in. Participants will not know and the study doctor will not know
which study group the participants are in.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Number of Impaired Neuropsychological Tests
The primary efficacy endpoint is to compare the number of impaired neuropsychological tests. The planned intervention period is three months. Neuropsychological outcomes will be examined using a 2 (group; COGNUTRIN, placebo) X 2 (time; baseline, three-months) repeated measures ANOVA to functioning, depression and fatigue will be evaluated for association with neurocognitive performance and entered as covariates in statistical analyses if a marginally significant association (p<.10) is observed. Changes in cognitive function: Number of impaired neuropsychological tests after 3 months of intervention with COGNUTRIN vs. placebo.
Nagi Kumar, Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|