Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy

Recruiting

• Conditions: Cognitive Dysfunction; Cognitive Change; Chemo Fog; Chemotherapy Effect; Cognitive Decline; Chemo-brain; Neoplasm, Colorectal; Cognitive Impairment

• Registration Number: NCT05014399
• Lead Sponsor: Joseph McCollom

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-20
• Study Start: 2021-09-20
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-15
• Primary Completion: 2025-10
• Study Completion: 2030-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Parkview Cancer Institute; 🇺🇸 Fort Wayne, Indiana, United States