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Could chia seeds ease chemo side effects? tiny study aims to find out

NCT ID NCT07553234

Knowledge-focused Sponsor: University of Chicago Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how gut bacteria affect diarrhea and other stomach issues in people with HR+/HER2- breast cancer taking the drug abemaciclib. In the first part, researchers will collect stool samples to track bacteria changes. In the second part, a small group will try eating chia seeds daily to see if it helps. Only 20 people will take part, and the main goal is to see if collecting samples is practical.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Chia seeds (fiber supplement)
What this could lead to
If successful, this could point toward simple dietary changes to reduce diarrhea and other gut side effects from breast cancer treatment.
What could go wrong
This is a very small pilot study (20 people) that is not yet recruiting. It mainly tests whether collecting stool samples is feasible, not whether the diet works. Results may not apply to other patients.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

May 2030

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.

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: * Be willing and able to provide written informed consent for the trial * Be a male or female subject 18 years of age on day of signing informed consent. * Histologically proven infiltrating carcinoma of the breast on core needle biopsy that is: HER2 negative in primary tumour pre-treatment by local pathology assessed according current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines: In situ hybridization non-amplified (ratio of HER2 to CEP17 \< 2.0 or single probe average HER2 gene copy number \< 4 signals/cell), OR Immunohistochemistry (IHC) 0 or IHC 1+. * Estrogen receptor (ER) and progesterone receptors (PR) positive in primary tumour pre-treatment defined as \>1% of cells expressing hormonal receptors via IHC analysis by local laboratory assessment. * Planned to undergo standard of care therapy with abemaciclib and endocrine therapy, in the adjuvant or metastatic setting (Part 1) or the adjuvant setting (Part 2). * Be willing to provide mandatory stool samples at baseline and on treatment. * The Eastern Cooperative Oncology Group (ECOG) 0-2 Exclusion Criteria: * Patients who are pregnant or breast-feeding * Current use of any investigational agents * Uncontrolled Ulcerative Colitis, Crohn's Disease, Malabsorption syndrome or any disease significantly affecting gastrointestinal function * History or current evidence of any condition, therapy, lab abnormality or other circumstance that in the opinion of the investigator might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject's participation for the full duration of the trial.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

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

  • The University of Chicago Medicine Comprehensive Cancer Center

    Chicago, Illinois, 60637, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.