Cognitive Changes in Adult Cancer Survivors (CFCC)
|ClinicalTrials.gov Identifier: NCT01569932|
Recruitment Status : Completed
First Posted : April 3, 2012
Last Update Posted : February 26, 2013
This study will document the cognitive (mental) and functional abilities of newly diagnosed cancer patients. The study will also examine the changes in cognitive and functional abilities during and after chemotherapy (your cancer treatment).
A comprehensive set of questionnaires and tasks, or assessments, have been put together in order for doctors and nurses to learn more about the day to day functioning of newly diagnosed adult cancer patients. The investigators would also like to follow up with the same adult patients, during and following completion of their cancer treatment, to learn about the kinds of treatments they received and how their cognitive status and level of participation in activities of daily living has changed. With follow-up assessments, doctors and nurses can learn more about the complications or health problems that adult patients may experience as a result of undergoing cancer therapy. This is a study involving two visits. The first visit occurs within two weeks before starting your cancer therapy, specifically chemotherapy. The second visit occurs within two weeks of completing your chemotherapy.
|Condition or disease|
|Effects of Chemotherapy Cognitive Impairment|
Chemotherapy is increasingly used in the management of various cancers. There are reports in the literature of chemotherapy-induced cognitive impairments ranging from deficits in memory and attention to slowed information-processing and deficiencies in executive function, including planning and problem-solving. These deficits have been shown to affect work-place productivity and social role-functioning which present significant public health risks in an era of increased chemotherapy usage. However, previous studies investigating cognitive deficits after chemotherapy have mainly used neurocognitive assessments, which are limited in their utility for clinical diagnosis due to their likelihood for practice effects and low sensitivity for detecting subtle cognitive changes that may be functionally relevant to the patient.
Resting-state functional connectivity magnetic resonance imaging (fcMRI) is a sensitive test that measures resting-state neural network connectivity, reflecting the integrity between functionally-related brain regions. fcMRI has been used to delineate cortical neural networks involved in a variety of cognitive domains, including memory, and attention. The investigators believe that fcMRI will be more sensitive than neurocognitive tests alone for investigating chemotherapy-induced cognitive changes. The goal of this novel study is to use fcMRI to investigate cognitive changes after chemotherapy in an attempt to understand the currently unknown neurobiological mechanisms associated with this phenomenon.
This prospective study will investigate the presence of cognitive deficits after chemotherapy in cancer patients by assessing changes in three fcMRI-defined neural networks involved in cognition. The three networks include (1) Dorsal Frontal Attention network (2) "Default" network and (3) Cognition "Core" control network. Sixteen cancer patients scheduled for chemotherapy will undergo fcMRI of the brain and neurocognitive testing within two weeks before and after chemotherapy. Comparisons between time-points will establish the effect of chemotherapy on cognition.
Results obtained from this study in cancer patients will provide insight into the mechanisms underlying the development of chemotherapy-induced cognitive deficits. Knowledge of the development of chemotherapy-induced cognitive deficits will enhance positive outcomes by allowing practitioners and patients to be better informed of the potential cognitive consequences to anticipate. With patients equipped with such information before starting cancer treatment, they will be better able to manage their affairs and daily activities in such a way that allows them to maintain productive living through their course of cancer and its treatment.
|Study Type :||Observational|
|Actual Enrollment :||13 participants|
|Official Title:||Cognitive and Functional Changes With Chemotherapy in Adult Cancer|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Patients will be assessed both before and after they undergo treatment with chemotherapy.
- Change in fcMRI [ Time Frame: before and after chemotherapy ]Baseline and post-chemotherapy fcMRI maps will be compared for changes in degree of activation within the cognition-associated cortical networks. To compute statistical significance, correlation co-efficients from the fcMRI will be converted to a normal distribution using Fischer's r-to-z transformation.
- Correlation of change in fcMRI with change in neurocognitive test scores. [ Time Frame: Baseline and at the completion of chemotherapy. Baseline visit must be no more than 2 weeks prior to start of chemotherapy. 2nd visit must occur within 2 weeks of last dose of chemotherapy. ]To assess the correlation between changes in cognition defined through standard neurocognitive tests and fcMRI among adult cancer patients after chemotherapy.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569932
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Jay F Piccirillo, MD||Washington University School of Medicine|