Chemo-brain, Chemo Fog, Chemotherapy Effect, Cognitive Change, Cognitive Decline, Cognitive Dysfunction, Cognitive Impairment, Neoplasm, Colorectal
Conditions
Keywords
Palliative Care, Palliative Oncology, Supportive Care, Supportive Oncology, Cognitive Impairment, Chemo Brain
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.
Interventions
None listed
Sponsors
Joseph McCollom
Indiana University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survey | 7 Years | FACT-Cog V3 |
| The Proteome Profiler Human XL Cytokine Array Kit (https://www.rndsystems.com/products/proteome-profiler-human-xl-cytokine-array-kit_ary022b) | 7 years | This panel of plasma factors will be will be used to detect protein from the blood of patients throughout and after chemotherapy treatment. |
Countries
United States
Contacts
CONTACTJoseph McCollom, DO
CONTACTEmily Powell, PHD
PRINCIPAL_INVESTIGATORJoseph McCollom, DO
Parkview Health
Outcome results
None listed