Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05014399
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Joseph McCollom
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Joseph McCollom, DO
Principal Investigator Affiliation	Parkview Health
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neoplasm, Colorectal, Cognitive Impairment, Cognitive Dysfunction, Cognitive Change, Chemo-brain, Chemo Fog, Chemotherapy Effect, Cognitive Decline

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Parkview Cancer Institute, Fort Wayne, Indiana

Status

Recruiting

Address

Parkview Cancer Institute

Fort Wayne, Indiana, 46845

Site Contact

Dr Joseph McCollom, DO

[email protected]

260-266-7100

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