Clinical trial NCT05014399: Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
Official title: Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neoplasm, Colorectal
Cognitive Impairment
Cognitive Dysfunction
Cognitive Change
Chemo-brain
Chemo Fog
Chemotherapy Effect
Cognitive Decline
Keywords: Palliative Care
Palliative Oncology
Supportive Care
Supportive Oncology
Cognitive Impairment
Chemo Brain
Lead sponsor: Parkview Health
Sponsor class: OTHER
Collaborators: name: Indiana University School of Medicine
First posted: 2021-08-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ambulatory colorectal oncology patients undergoing cytotoxic therapy.

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.

Primary outcomes:
measure: Survey
timeFrame: 7 Years
measure: The Proteome Profiler Human XL Cytokine Array Kit (https://www.rndsystems.com/products/proteome-profiler-human-xl-cytokine-array-kit_ary022b)
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Parkview Cancer Institute
state: Indiana
Study officials:
affiliation: Parkview Health
name: Joseph McCollom, DO
role: PRINCIPAL_INVESTIGATOR
References: