Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy

NCT05014399 | Recruiting

• 1 other identifier: PRC-ONCOLOGY-21-0628-PPG
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Palliative Care; Palliative Oncology; Supportive Care; Supportive Oncology; Cognitive Impairment; Chemo Brain

Outcome Measures

Primary Outcomes (2)

• Survey

  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)

  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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All self representation of gender identity accepted
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ambulatory colorectal oncology patients undergoing cytotoxic therapy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joseph McCollom: lead
• Indiana University School of Medicine: collaborator

Study Sites (1)

Parkview Cancer Institute

Fort Wayne, Indiana, 46845, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood samples

MeSH Terms

Conditions

Colorectal Neoplasms; Cognitive Dysfunction; Chemotherapy-Related Cognitive Impairment

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Joseph McCollom, DO

  Parkview Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph McCollom, DO

CONTACT

260-266-7100; joseph.mccollom@parkview.com

Emily Powell, PHD

CONTACT

emily.powell@parkview.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Oncologist

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 20, 2021
• Study Start: September 20, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2031
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)