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Gut bugs linked to chemo side effects? new study investigates

NCT ID NCT05417867

Knowledge-focused Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study looks at whether changes in gut bacteria are linked to fatigue and nausea in women with early-stage breast cancer undergoing chemotherapy. Researchers will collect stool and blood samples and have participants fill out questionnaires before and after treatment. The goal is to better understand why some patients experience these side effects more than others.

What this could mean

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

What this could lead to
If successful, this study could point toward ways to predict or manage fatigue and nausea in breast cancer patients by targeting the gut microbiome.
What could go wrong
This is a small pilot study (70 participants) focused on observation, not treatment. It may not find clear links, and results may not apply to all 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.

Participants

About 70 people

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

Started

Apr 2021

Expected to finish

Mar 2027

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

Subjects with a diagnosis of early stage breast cancer, planning to receive moderate to highly emetogenic chemotherapy will be recruited at Mayo Clinic Health Systems including Mankato and Albert Lea, Mayo Clinic Arizona, Mayo Clinic, Minnesota, and Mayo Clinic Florida.

Ages

20 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: * Subjects with a diagnosis of early stage breast cancer planning to receive moderate to highly emetogenic chemotherapy will be recruited at Mayo Clinic Health Systems including Mankato and Albert Lea; Mayo Clinic Arizona; Mayo Clinic Rochester (Minnesota); and Mayo Clinic Florida * At least 20 years of age * Last chemotherapy more than 3 years ago * Scheduled to receive moderate to highly emetogenic chemotherapy with or without targeted therapies including immunotherapies Exclusion Criteria: * Metastatic disease * Concurrent radiation therapy * Concurrent antibiotic treatment

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma chemotherapy-induced toxicity

As listed by the trial registrant

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

Anatomic stage I breast cancer ajcc V8 Anatomic stage II breast cancer ajcc V8 Chemotherapy-related nausea and/or vomiting Early-stage breast carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    4 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

  • Mayo Clinic Health System in Albert Lea

    RECRUITING

    Albert Lea, Minnesota, 56007, United States

    Contact Email: •••••@•••••

  • Mayo Clinic Health System in Mankato

    RECRUITING

    Mankato, Minnesota, 56001, United States

    Contact Email: •••••@•••••

  • Mayo Clinic in Arizona

    SUSPENDED

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic in Florida

    ACTIVE_NOT_RECRUITING

    Jacksonville, Florida, 32224-9980, United States

  • Mayo Clinic in Rochester

    SUSPENDED

    Rochester, Minnesota, 55905, United States

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