Condition: Early Breast Cancer · Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
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 en…
This description comes directly from the study's public registry record.
Frede Donskov, Clinical Professor, MD, DMSc, · +45 2053 3235 · fdonskov@health.sdu.dk
Lone Gamrath, PhD Fellow · +45 2920 3221 · Lone.Gamrath@rsyd.dk
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| University Hospital of Southern Denmark, Esbjerg | Esbjerg, Denmark | Recruiting |
| Sygehus Lillebaelt, Vejle | Vejle, Denmark | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07007169