Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy (Chemo Brain)

November 14, 2023 updated by: Joseph McCollom
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Ambulatory colorectal oncology patients undergoing cytotoxic therapy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survey
Time Frame: 7 Years
FACT-Cog V3
7 Years
The Proteome Profiler Human XL Cytokine Array Kit (https://www.rndsystems.com/products/proteome-profiler-human-xl-cytokine-array-kit_ary022b)
Time Frame: 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.
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joseph McCollom

Collaborators

Indiana University School of Medicine

Investigators

  • Principal Investigator: Joseph McCollom, DO, Parkview Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2021

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2030

Study Registration Dates

First Submitted

August 3, 2021

First Submitted That Met QC Criteria

August 17, 2021

First Posted (Actual)

August 20, 2021

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRC-ONCOLOGY-21-0628-PPG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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