ClinicalTrials.gg
RecruitingNCT05014399Chemo BrainUpdated Aug 14, 2026

Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy

An observational study in Neoplasm, Colorectal, Cognitive Impairment and Cognitive Dysfunction, sponsored by Joseph McCollom. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Joseph McCollom · Observational

From the registry’s dates

  • Started Sep 2021; still recruiting 5 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Colorectal Neoplasms

6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.

This study's planned enrollment of 60 is below the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

This is the only study on the registry with Joseph McCollom as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Ambulatory colorectal oncology patients undergoing cytotoxic therapy.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Signed written 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 -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

Exclusion Criteria:

  • Prior administration of anti-cancer chemotherapy, radiotherapy, immunotherapy, or agents
  • Patients having mental incompetence as assessed by study PI, which would hinder completion of the surveys
  • Pregnant or breastfeeding
  • Any known
  • 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Survey

    FACT-Cog V3

    Time frame: 7 Years

  2. 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.

    Time frame: 7 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05014399
Lead sponsor
Joseph McCollom
Collaborators
Indiana University
Responsible party
Joseph McCollom (Oncologist, Parkview Health) — Sponsor-investigator
First posted
Aug 20, 2021
Start date
Sep 20, 2021
Primary completion
Oct 2028 (estimated)
Completion
Oct 2031 (estimated)
Last update
Aug 14, 2026

Study contacts

Joseph McCollom, DO
Contact
joseph.mccollom@parkview.com
260-266-7100
Emily Powell, PHD
Contact
emily.powell@parkview.com
Joseph McCollom, DO
principal investigator · Parkview Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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