Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Neoplasm, Colorectal, Cognitive Impairment, Cognitive Dysfunction, Cognitive Change. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Survey [Time frame: 7 Years]
- The Proteome Profiler Human XL Cytokine Array Kit (https://www.rndsystems.com/products/proteome-profiler-human-xl-cytokine-array-kit_ary022b) [Time frame: 7 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Parkview Cancer Institute — Fort Wayne
Identifiers
NCT: NCT05014399 · PRC-ONCOLOGY-21-0628-PPG