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https://pubmed.ncbi.nlm.nih.gov/34941392Actively Recruiting
Phase 2
Age: 18Years +
All Genders
Healthy Volunteers
ID07007169
Mediterranean Diet and Inequality in Early Breast Cancer: A Multicenter Randomized Clinical Trial
Led by Esbjerg Hospital - University Hospital of Southern Denmark · Updated on 2026-01-02
105
Participants Needed
2
Research Sites
469 weeks
Total Duration
On this page
Sponsors
E
Esbjerg Hospital - University Hospital of Southern Denmark
Lead Sponsor
V
Vejle Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research investigates whether following the Mediterranean diet can affect the gut microbiome, quality of life, well-being, immune activity, and treatment outcomes in patients with early breast cancer undergoing (neo)adjuvant chemotherapy. The study also examines if these effects are stronger among patients facing challenging socioeconomic conditions. The Mediterranean diet emphasizes plant foods, such as vegetables, fruits, nuts, seeds, berries, legumes, herbs, and spices, with animal proteins like fish, meat, and cheese, and olive oil as the main fat source. Breast cancer is common and serious, and socioeconomic factors influence patient outcomes. Participants will be randomly assigned in a 2:1 ratio to either follow the Mediterranean diet with personalized guidance from a nutrition therapist aiming for daily intake of 30 grams of dietary fiber and 30 different plant foods per week while minimizing ultra-processed foods, or to continue their usual diet. Nutritional support includes weekly sessions during chemotherapy visits or via online or home visits, access to educational materials and recipes, and group sessions. The study period covers from before chemotherapy start until the beginning of the sixth chemotherapy cycle, with sample collections and assessments scheduled throughout. During the study, patients will provide stool and blood samples for microbiome and immune system analysis, complete questionnaires on quality of life and well-being, and record their dietary intake using an app and paper logs. Researchers will monitor immune cells, short-chain fatty acids, socioeconomic data, and clinical outcomes including survival and cancer recurrence for up to 10 years. Safety is expected to be minimal due to the nature of the dietary intervention, and participants may stop the trial at any time while continuing their usual medical care.
CONDITIONS
Brief Title
Mediterranean Diet and Inequality in Early Breast Cancer
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Signed written informed consent approved by the Ethical Review Board.
- Age 18 years or older.
- Histologically confirmed unilateral adenocarcinoma of the breast, stage I-III.
- Candidates for neoadjuvant chemotherapy followed by curative surgery, or adjuvant chemotherapy after curative surgery.
- Good performance status (WHO 0 or 1).
- Willing to undergo treatment and study procedures.
- Have a smartphone or computer to receive emails for dietary tracking.
- Willing to avoid probiotic supplements during the study; fermented foods allowed.
You will not qualify if you...
- 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 such as gastric bypass surgery, Crohn's disease, or ulcerative colitis.
- Unable to communicate effectively in Danish or English.
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 18 weeks (through chemotherapy cycles 1 to 6, each cycle 2 to 3 weeks)
Participants follow either the Mediterranean diet with personalized nutritional guidance or continue their standard diet while undergoing (neo)adjuvant chemotherapy for early breast cancer. Nutritional guidance includes weekly outpatient chemotherapy visits or online/home support for the first month, then every other week. Dietary adherence is tracked through food diaries and weekly plant intake records.
Weekly visits for the first 4 weeks, then every other week until start of cycle 6
Follow-up
Duration - Up to 10 years
Participants' invasive disease-free survival, distant recurrence-free survival, and overall survival are monitored through national registries for up to 10 years after treatment completion.
No additional visits; monitoring via registries
Trial Site Locations
Total: 2 locations
1
University Hospital of Southern Denmark, Esbjerg
Esbjerg, Denmark, 6700
Actively Recruiting
2
Sygehus Lillebaelt, Vejle
Vejle, Denmark, 7100
Actively Recruiting
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Research Team
F
Frede Donskov, Clinical Professor, MD, DMSc,
L
Lone Gamrath, PhD Fellow
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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