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Mediterranean diet may boost gut health and Well-Being in breast cancer patients

NCT ID NCT07007169

Disease control Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times

Summary

This study looks at whether eating a Mediterranean diet (rich in vegetables, fruits, nuts, fish, and olive oil) can improve gut health, quality of life, and treatment outcomes for women with early breast cancer undergoing chemotherapy. About 105 participants will be randomly assigned to either follow the Mediterranean diet with guidance or continue their usual diet. The main goal is to see changes in gut bacteria, but researchers will also measure immune function, well-being, and how social factors like income and education affect results.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 105 people

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

Started

Mar 2025

Expected to finish

Mar 2036

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

Accepted

You do not need to have the condition being studied to take part.

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: 1. Signed written informed consent approved by the Ethical Review Board. 2. Age ≥ 18 3. Histologically confirmed unilateral adenocarcinoma of the breast, stage I-III, candidates for neoadjuvant chemotherapy followed by curative surgery, or adjuvant chemotherapy after curative surgery, according to the Danish Breast Cancer Group guidelines 48. The addition of trastuzumab and pertuzumab in HER2-positive tumors, or pembrolizumab in triple-negative tumors, per Danish Breast Cancer Group guidelines 48, is allowed as an adjunct to chemotherapy. 4. Good performance status (WHO performance status 0 or 1). 5. Willingness by the patient to undergo treatment and study-related procedures according to the protocol. 6. Have a smartphone or computer to which it is possible to receive emails (for food diary; www.myfood24.org) 7. Must be willing to restrict from probiotic (living microorganisms) supplements during the study. Fermented foods are allowed. \- Exclusion Criteria: 1. Clinical or radiological signs of metastatic disease. 2. History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or non-melanoma skin cancer. 3. Previous chemotherapy for cancer or other malignant disease. 4. Major altered digestive system disorders (e.g. gastric by-pass or Crohn's disease or ulcerative colitis) 5. Unable to communicate effectively in Danish or English.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Early 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

    3 sites. 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

  • Hospital of Southern Jutland

    RECRUITING

    Sønderborg, Southern Denmark, 6400, Denmark

  • Sygehus Lillebaelt, Vejle

    RECRUITING

    Vejle, 7100, Denmark

  • University Hospital of Southern Denmark, Esbjerg

    RECRUITING

    Esbjerg, 6700, Denmark

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