Mediterranean diet and socioeconomic differences in early breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II interdisciplinary trial combines nutrition, sociology, and oncology to see if adherence to a Mediterranean diet alters the microbiome and supports patients through (neo)adjuvant chemotherapy for stage I–III breast cancer. Participants are asked to meet daily and weekly dietary targets (minimum 30 g fiber per day and at least 30 different plant foods per week) while minimizing ultra-processed foods and avoiding probiotic supplements, with intake logged electronically. Outcomes include changes in microbiome composition, short-chain fatty acid levels, immune activity, patient-reported quality of life and empowerment, and clinical cancer outcomes. The study focuses on whether benefits are greater among patients with unfavorable socioeconomic determinants and is conducted at hospitals in Southern Denmark.

Why it matters

Who can join: the full rules

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.

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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.

Where it's running

• Hospital of Southern Jutland
  Sønderborg, Southern Denmark, Denmark Recruiting
• University Hospital of Southern Denmark, Esbjerg
  Esbjerg, Denmark Recruiting
• Sygehus Lillebaelt, Vejle
  Vejle, Denmark Recruiting

Study contacts

• Study coordinator: Frede Donskov, Clinical Professor, MD, DMSc,
• Email: fdonskov@health.sdu.dk
• Phone: +45 2053 3235

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.