Examining brain changes in colorectal cancer patients undergoing chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate how chemotherapy affects cognitive function in patients with colorectal cancer. It will focus on identifying changes in thinking and memory as a result of cytotoxic drug treatments. The research will involve patients receiving specific chemotherapy agents and will utilize various tests to assess cognitive impairment. The findings may help in developing diagnostic tools for those at risk of cognitive dysfunction due to cancer treatments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Parkview Cancer Institute
  Fort Wayne, Indiana, United States Recruiting

Study contacts

• Principal investigator: Joseph McCollom, DO — Parkview Health
• Study coordinator: Joseph McCollom, DO
• Email: joseph.mccollom@parkview.com
• Phone: 260-266-7100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.