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Can we predict chemo brain before it happens?

NCT ID NCT05014399

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Oct 2031

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

chemotherapy-induced toxicity Chemotherapy-Related Cognitive Impairment cognitive disorder Cognitive Dysfunction colorectal cancer colorectal neoplasm

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Parkview Cancer Institute

    RECRUITING

    Fort Wayne, Indiana, 46845, United States

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