Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy

Recruiting now

Conditions studied: Neoplasm, Colorectal, Cognitive Impairment, Cognitive Dysfunction, Cognitive Change, Chemo-brain, Chemo Fog, Chemotherapy Effect, Cognitive Decline

In brief

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.

Key facts

Study ID

NCT05014399

Run by

Joseph McCollom

People needed

60

Starts

2021-09-20

Expected to finish

2031-10-01

Last updated by the study team

2025-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Parkview Cancer Institute — Fort Wayne, Indiana, United States (enrolling)

Full record on ClinicalTrials.gov

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