Mediterranean Diet and Inequality in Early Breast Cancer

Recruiting now · Phase 2

Conditions studied: Early Breast Cancer

In brief

Social determinants such as education, income, marital status, and social networks play a crucial role in cancer outcomes, including breast cancer. One potential influencing factor is diet, and the Mediterranean diet has been shown to benefit both the health and the microbiome. This raises the question: Does adherence to the Mediterranean diet impact the microbiome, quality of life, overall well-being, and outcomes in breast cancer patients undergoing (neo)adjuvant treatment, particularly among those with unfavorable socioeconomic determinants? The Mediterranean diet consists of plant foods such as vegetables, fruits, nuts, seeds, berries, legumes, herbs, and spices. It also features animal proteins like fish, meat, and cheese, along with fat from olive oil. Thus, adherence to the Mediterranean diet is adherence to the official Danish diet recommendations. This phase II clinical trial is an interdisciplinary study combining nutrition, sociology, and health research. Breast cancer patients candidates for (neo)adjuvant treatment at four oncology departments in Region South Denmark will be randomized 2:1 to the Mediterranean diet (with individual dietary guidance from a nutrition therapist aiming at daily consumption of a minimum of 30 grams of dietary fiber and weekly consumption of a minimum of 30 different plant foods; minimizing the amount of ultra-processed food) versus the patient's regular diet, in conjuction with the (neo)adjuvant chemotherapy. The trial's primary endpoint will be changes in gut microbiota composition in feces. The study evaluates how the Mediterranean diet affects the microbiota (evaluated using Oxford Nanopore Technology 16S sequencing on fecal samples); short-chain fatty acids in stool and plasma (assessed by mass spectrometry); immune system (using flow cytometry for immune cell determination in blood and immunohistochemical determination of immune cells in the tumor tissue); and patients' social quality of life, overall well-being, sense of empowerment, and personal feeling of agency (using the WHOQOL-100 questionnaire); taking into account the impact of the distance from the patient residence to the hospital (tracked from GEOTEAM at Statistics Denmark), and socioeconomic factors (using the DREAM database). The evaluation of biological parameters is based on the suggested mechanism of action. A diet rich in various plant foods and dietary fiber will alter the gut microbiota, promoting bacteria producing high amounts of short-chain fatty acids. These fatty acids will activate immune cells, aiding in the destruction of cancer cells. The study will also assess whether the Mediterranean diet will positively impact the patients' social quality of life, overall well-being, sense of empowerment, and personal feeling of agency. The Mediterranean diet may not only lead to improved dietary habits but also serve as a crucial tool for breast cancer patients, particularly among those with unfavorable socioeconomic determinants. Enhanced empowerment and improved coping tools could be an important step in combating cancer-related inequalities.

Key facts

Study ID: NCT07007169
Run by: Esbjerg Hospital - University Hospital of Southern Denmark
People needed: 105
Starts: 2025-03-27
Expected to finish: 2036-03-01
Last updated by the study team: 2026-01-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Signed written informed consent approved by the Ethical Review Board.
Age ≥ 18
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.
Good performance status (WHO performance status 0 or 1).
Willingness by the patient to undergo treatment and study-related procedures according to the protocol.
Have a smartphone or computer to which it is possible to receive emails (for food diary; www.myfood24.org)
Must be willing to restrict from probiotic (living microorganisms) supplements during the study. Fermented foods are allowed.

You may not qualify if…

Clinical or radiological signs of metastatic disease.
History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or non-melanoma skin cancer.
Previous chemotherapy for cancer or other malignant disease.
Major altered digestive system disorders (e.g. gastric by-pass or Crohn's disease or ulcerative colitis)
Unable to communicate effectively in Danish or English.

Where it is running

University Hospital of Southern Denmark, Esbjerg — Esbjerg, Denmark (enrolling)
Sygehus Lillebaelt, Vejle — Vejle, Denmark (enrolling)

Full record on ClinicalTrials.gov

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