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Recruiting

NCT Number: NCT05014399

Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy

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.

Recruiting

Interested in participating?

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Survey

    Time frame: 7 Years

    FACT-Cog V3

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Powell, PHD

CONTACT

[email protected]

Joseph McCollom, DO

CONTACT

[email protected]

260-266-7100

Sponsors and collaborators

Lead sponsor

Joseph McCollom

Other

Collaborators

  • Indiana University

Registry information

Acronym: Chemo Brain

Important dates

Study start
2021
Primary completion
2026
Study completion
2031
First posted
Aug 20, 2021
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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