Examining brain changes in colorectal cancer patients undergoing chemotherapy
Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
This study is trying to see how chemotherapy affects thinking and memory in people with colorectal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Parkview Health Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Fort Wayne, Indiana) |
| Trial ID | NCT05014399 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with a histologically-confirmed colorectal tumor who are about to start cytotoxic chemotherapy.
Not a fit: Patients who have previously received chemotherapy or have mental incompetence that affects their ability to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better diagnostic methods for identifying cognitive impairment in cancer patients, improving their overall care.
How similar studies have performed: While cognitive impairment in cancer patients has been studied, this specific approach focusing on colorectal cancer and chemotherapy effects is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Fort Wayne, Indiana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.