NCT05014399 Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
| NCT ID | NCT05014399 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Joseph McCollom |
| Condition | Neoplasm, Colorectal |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-09-20 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2021-09-20 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Joseph McCollom, DO
PRINCIPAL INVESTIGATOR
Parkview Health
Frequently Asked Questions
Who can join the NCT05014399 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neoplasm, Colorectal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05014399 currently recruiting?
Yes, NCT05014399 is actively recruiting participants. Contact the research team at joseph.mccollom@parkview.com for enrollment information.
Where is the NCT05014399 trial being conducted?
This trial is being conducted at Fort Wayne, United States.
Who is sponsoring the NCT05014399 clinical trial?
NCT05014399 is sponsored by Joseph McCollom. The principal investigator is Joseph McCollom, DO at Parkview Health. The trial plans to enroll 60 participants.