Could a Gut-Healthy diet help breast cancer treatment work better?
NCT ID NCT07311083
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
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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
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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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Feb 2026
- Expected to finish
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Jul 2027
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.
- Ages
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18 to 75 years
- Sex
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Female participants only
- 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: * 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.
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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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Evang. Kliniken Essen-Mitte gGmbH
RECRUITINGEssen, North Rhine-Westphalia, 45276, Germany
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