Actively Recruiting
Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
Led by Joseph McCollom · Updated on 2025-06-11
60
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
J
Joseph McCollom
Lead Sponsor
I
Indiana University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how the brain changes in patients with colorectal cancer who receive cytotoxic chemotherapy treatments such as Capecitabine, Oxaliplatin, 5 fluorouracil, and Irinotecan. The purpose is to identify tests that can diagnose people at risk of developing difficulties with thinking and memory caused by their cancer treatment. This observational study focuses on cognitive impairment related to chemotherapy effects in adults with histologically confirmed colorectal tumors. Participants in this study will be those who have not previously received cytotoxic chemotherapy and will be monitored during their treatment for brain and cognitive changes. There are no experimental drugs or placebo groups since this is an observational study. The study collects information over a period of up to 7 years, including surveys and laboratory tests using the Proteome Profiler Human XL Cytokine Array Kit to track changes related to chemotherapy. During the study, participants will complete surveys and have biological samples analyzed to assess cognitive function and possible immune system changes. Researchers will review these measures to better understand chemotherapy-related cognitive decline. The study requires signed informed consent and follows strict privacy guidelines. Participation involves long-term observation without altering standard medical care, and data will be collected to improve diagnosis and support for patients experiencing chemo-brain symptoms.
CONDITIONS
Brief Title
Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent according to ICH-GCP, local regulations, and HIPAA
- Histologically confirmed colorectal tumor
- Planned treatment with cytotoxic chemotherapy including Capecitabine, Oxaliplatin, 5 fluorouracil, or Irinotecan
- No prior cytotoxic chemotherapy received before enrollment
You will not qualify if you...
- Prior use of anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents
- Mental incompetence hindering survey completion
- Pregnant or breastfeeding
- Known brain metastases
- Non-English speaking
- Diagnosis of neuro-cognitive disorders such as traumatic brain injury, Alzheimer's disease, Parkinson's disease, Huntington's disease, or Creutzfeldt-Jakob disease
- Deemed inappropriate to participate by study PI or coordinator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 7 years
Participants are observed to assess cognitive impairment while receiving cytotoxic chemotherapy for colorectal cancer.
Surveys and blood sample collections during treatment and follow-up visits
Trial Site Locations
Total: 1 location
1
Parkview Cancer Institute
Fort Wayne, Indiana, United States, 46845
Actively Recruiting
Research Team
J
Joseph McCollom, DO
E
Emily Powell, PHD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here