Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
Recruiting · NCT05014399 · Observational (researchers observe without assigning treatment) · Lead sponsor: Joseph McCollom
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
1 location listed across 1 US state.
- Parkview Cancer Institute - Fort Wayne, Indiana, United States