The purpose of this study is to examine the effects of immunotherapy on cognitive function of cancer patients and follow them clinically over a period of six months with the Montreal cognitive assessment (MoCA) to assess changes in cognition.
"Chemo brain" has been described as a side effect of conventional chemotherapy and radiotherapy in cancer patients. With the advent of immunotherapy and progress made in treatment of cancer, long term-survival has increased which raises the question of preserving cognitive function in these patients. However, to date, no large center studies have been done to assess the effects of immunotherapy on cognitive function in patients of all cancer types. Studies that have been done are on preclinical models and very small number of patients, which remained inconclusive. The primary objective of this pilot clinical trial is to estimate the rate of cognitive function change using the MoCA scale over 6 months in each individual group of patients with cancer treated with immunotherapy alone, combined chemotherapy and immunotherapy, and in patients with cancer on no active treatment, respectively. The secondary objective is to estimate the changes of MoCA scores after 3 months and 6 months in patients receiving immunotherapy alone for the treatment of their cancer.
Study Type
OBSERVATIONAL
Enrollment
54
MoCA is a method for evaluating cognition. This assessment will be conducted at baseline, month 3, and month 6.
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, United States
Rate of Cognitive Function Change
The changes in MoCA scores over 6 months in patients from each group will be plotted and summarized with mean change, standard deviation of change, and standard errors of mean change. The standardized response mean (SRM), calculated as the mean change from baseline to 6 months, divided by the standard deviation of change, will be reported as the main effect size for evaluating the magnitude of change in cognitive function.
Time frame: Baseline and 6 months
Changes in MoCA scores
Changes of MoCA scores at 3 months and 6 months from the immunotherapy group will be fitted by the mixed-effects linear model including time effects, which will describe the relationship between the common effect of MoCA score changes, the random effect of time, and the random error representing subjects' observation time.
Time frame: 3 and 6 months
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