RecruitingPhase 2NCT07007169

Mediterranean Diet and Inequality in Early Breast Cancer

Mediterranean Diet and Inequality in Early Breast Cancer: A Multicenter Randomized Clinical Trial


Sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Enrollment

105 participants

Start Date

Mar 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether following a Mediterranean diet during breast cancer chemotherapy can improve treatment outcomes and reduce inequalities in care. Patients will be guided through a dietary program while receiving standard chemotherapy. **You may be eligible if...** - You are 18 years or older - You have confirmed early-stage breast cancer (stage I–III) and are receiving or about to receive chemotherapy (neoadjuvant or adjuvant) - You are in good overall health (WHO performance status 0 or 1) - You have a smartphone or computer to access a digital food diary - You are willing to avoid probiotic supplements during the study **You may NOT be eligible if...** - You have signs of metastatic (spread) disease - You have had another cancer in the last 5 years (except cervical carcinoma in situ or non-melanoma skin cancer) - You have had prior chemotherapy for cancer - You have major digestive system problems (e.g., gastric bypass, Crohn's disease, ulcerative colitis) - You cannot communicate in Danish or English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTThe goal is 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.

The intervention group will receive personalized education and guidance from a nutrition therapist.

OTHERStandard Diet

The control group will continue their normal diet, and not receive guidance or participate in group sessions.


Locations(2)

University Hospital of Southern Denmark, Esbjerg

Esbjerg, Denmark

Sygehus Lillebaelt, Vejle

Vejle, Denmark

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NCT07007169


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