Recruiting

Chemotherapy

Sponsor:

Joseph McCollom

Code:

NCT05014399

Conditions

Neoplasm, Colorectal

Cognitive Impairment

Cognitive Dysfunction

Cognitive Change

Chemo-brain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05014399

Start date

Sep 20, 2021

Status verified date

Aug, 2026

Completion date

Oct, 2031

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Survey [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Joseph McCollom, DO

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

Emily Powell, PHD

emily.powell@parkview.com

Locations

Parkview Cancer Institute

Recruiting

Fort Wayne, Indiana, United States, 46845

Contacts

Dr Joseph McCollom, DO

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

More Information

Sponsor

Joseph McCollom

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Joseph McCollom on 2026-08-14.