Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy

Cognitive Impairment Clinical Trial

— Chemo Brain  

Official title:

Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05014399
• Other study ID #: PRC-ONCOLOGY-21-0628-PPG
• Status: Recruiting
• Start date: September 20, 2021
• Est. completion date: October 2030

Study information

• Verified date: November 2023
• Source: Parkview Health
• Contact: Joseph McCollom, DO
• Phone: 260-266-7100
• Email: joseph.mccollom[@]parkview.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2030
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chemo Fog
• Chemo-brain
• Chemotherapy Effect
• Cognitive Change
• Cognitive Decline
• Cognitive Dysfunction
• Cognitive Impairment
• Colorectal Neoplasms
• Neoplasm, Colorectal

Locations

Country	Name	City	State
United States	Parkview Cancer Institute	Fort Wayne	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Joseph McCollom	Indiana University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survey	FACT-Cog V3	7 Years
Primary	The Proteome Profiler Human XL Cytokine Array Kit (https://www.rndsystems.com/products/proteome-profiler-human-xl-cytokine-array-kit_ary022b)	This panel of plasma factors will be will be used to detect protein from the blood of patients throughout and after chemotherapy treatment.	7 years