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Could a Gut-Healthy diet help breast cancer treatment work better?

NCT ID NCT07311083

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a high-fiber diet (20-30 grams per day) combined with mind-body support can help women with triple-negative breast cancer undergoing immunotherapy and chemotherapy. Sixty participants will either receive online group training or a simple nutrition flyer. The main goal is to see if the diet change is feasible, not yet to measure cancer outcomes.

What this could mean

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

Active substance
high-fiber diet (20-30 g/day) plus mind-body behavioral support
What this could lead to
If this approach works, it could point toward a way to improve treatment response and reduce side effects for women with triple-negative breast cancer.
What could go wrong
This is a small, early feasibility study with only 60 participants. It is not designed to prove the diet improves outcomes, 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.

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 60 people

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

Started

Feb 2026

Expected to finish

Jul 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.

Ages

18 to 75 years

Sex

Female participants only

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: * Female patients aged 18-75 * Histologically confirmed diagnosis of non-metastatic triple-negative breast cancer (TNM stage I-III) with planned neoadjuvant chemotherapy and immunotherapy * Willingness to participate in the study and signed consent form Exclusion Criteria: * Advanced stage of disease with metastases * Severe physical or psychopharmacologically treated psychiatric comorbidity that prevents a patient from participating in the study * Pregnancy * Participation in other clinical studies involving behavioral, psychological, or complementary medical interventions * A diet that is incompatible with a high-fiber diet, such as the ketogenic diet * Abuse of drugs and/or alcohol * Inability to complete the questionnaires independently * Colectomy * Gastrointestinal stenosis * Fructose intolerance * Histamine intolerance * Gluten intolerance * Ketogenic diet * Unwillingness to refrain from taking probiotics for the duration of the study * Eating disorders * No laptop and/or camera available to participate in the online group training program

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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.

  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

  • Evang. Kliniken Essen-Mitte gGmbH

    RECRUITING

    Essen, North Rhine-Westphalia, 45276, Germany

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