Chemo Brain: Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy

Sponsor

Joseph McCollom (Other)

Overall Status

Recruiting

CT.gov ID

NCT05014399

Collaborator

Indiana University School of Medicine (Other)

Enrollment

Location

108.4

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research study is to see how the brain changes in patients receiving chemotherapy (cytotoxic drug) treatment for colon or rectal cancer at Parkview Cancer Institute. This information will be used to identify helpful tests to diagnose individuals at risk for developing difficulties with thinking and memory due to their cancer treatments.

Condition or Disease	Intervention/Treatment	Phase
Neoplasm, Colorectal Cognitive Impairment Cognitive Dysfunction Cognitive Change Chemo-brain Chemo Fog Chemotherapy Effect Cognitive Decline

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy

Actual Study Start Date :

Sep 20, 2021

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2030

Outcome Measures

Primary Outcome Measures

Survey [7 Years]
FACT-Cog V3
The Proteome Profiler Human XL Cytokine Array Kit (https://www.rndsystems.com/products/proteome-profiler-human-xl-cytokine-array-kit_ary022b) [7 years]
This panel of plasma factors will be will be used to detect protein from the blood of patients throughout and after chemotherapy treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPAA) prior to study-specific screening procedures. Must be able to provide study-specific informed consent prior to study entry.
A histologically-confirmed colorectal tumor
Patients who will be treated with cytotoxic chemotherapies including Capecitabine, Oxaliplatin, 5 fluorouracil, and Irinotecan are eligible.
Patients must not have received cytotoxic chemotherapy previous to enrollment.

Exclusion Criteria:

Prior administration of anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents
Patients having mental incompetence as assessed by study PI, which would hinder completion of the surveys
Pregnant or breastfeeding
Any known brain metastases
Non-English speaking patients
Patients who have been diagnosed with any neuro-cognitive disorder including traumatic brain injuries, Alzheimer's disease, Parkinson's disease, Huntington's disease, and Creutzfeldt-Jakob disease.
Patients deemed inappropriate to participate in this study by the study PI or coordinator will be excluded.