Neoplasm, ColorectalChemo BrainNCT05014399
Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
An observational study of Neoplasm, Colorectal and Cognitive Impairment, run by Joseph McCollom at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm, Colorectal, Cognitive Impairment, Cognitive Dysfunction
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2021to Oct 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ambulatory colorectal oncology patients undergoing cytotoxic therapy.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emily Powell, PHD contact
United States1 site, 1 recruiting
- Recruiting
Parkview Cancer Institute
Fort Wayne, Indiana, 46845
Dr Joseph McCollom, DO, 260-266-7100, joseph.mccollom@parkview.com
About this study
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.
- Conditions
- Neoplasm, Colorectal, Cognitive Impairment, Cognitive Dysfunction, Cognitive Change, Chemo-brain, Chemo Fog
- Keywords
- Palliative Care, Palliative Oncology, Supportive Care, Supportive Oncology, Cognitive Impairment, Chemo Brain
- Medical subject headings
- Colorectal Neoplasms, Cognitive Dysfunction, Chemotherapy-Related Cognitive Impairment
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey
FACT-Cog V3
Measured: 7 Years
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.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start20 Sep 2021
- Primary completionOct 2028 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm, ColorectalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joseph McCollom
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University
- Responsible party
- Sponsor-investigator, Joseph McCollom, Parkview Health
- Investigators
- Joseph McCollom, DO, Principal investigator, Parkview Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014399
- Sponsor's protocol ID
- PRC-ONCOLOGY-21-0628-PPG
- Acronym
- Chemo Brain
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2021
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
- ClinicalTrials.gov ID
- NCT05014399
- Acronym / sponsor ID
- Chemo Brain / PRC-ONCOLOGY-21-0628-PPG
- Conditions
- Neoplasm, Colorectal, Cognitive Impairment, Cognitive Dysfunction, Cognitive Change, Chemo-brain, Chemo Fog
- Keywords
- Palliative Care, Palliative Oncology, Supportive Care, Supportive Oncology, Cognitive Impairment, Chemo Brain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Joseph McCollomUniversity, hospital or other
- Collaborators
- Indiana University
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ambulatory colorectal oncology patients undergoing cytotoxic therapy.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survey
Time frame: 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)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Neoplasm, Colorectal
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Powell, PHD contact
Joseph McCollom, DO principal investigator
Parkview Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasm, Colorectal and Cognitive Impairment, run by Joseph McCollom at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph McCollom, DO (260-266-7100, joseph.mccollom@parkview.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survey (time frame: 7 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.