Can we predict chemo brain before it happens?
NCT ID NCT05014399
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This study looks at how chemotherapy for colon or rectal cancer affects thinking and memory. Researchers will track changes in brain function and blood proteins in 60 patients during and after treatment. The goal is to find tests that could identify who is at risk for 'chemo brain' and help manage these side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cytotoxic chemotherapy
- What this could lead to
- If successful, this could lead to better ways to identify patients at risk for chemo-related memory and thinking problems, enabling earlier support and interventions.
- What could go wrong
- This is an observational study with a small number of participants, so findings may not apply to all patients. It does not test a treatment, so it won't directly improve cognitive function.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2021
- Expected to finish
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Oct 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Ambulatory colorectal oncology patients undergoing cytotoxic therapy.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Parkview Cancer Institute
RECRUITINGFort Wayne, Indiana, 46845, United States
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