NCT07007169 Mediterranean Diet and Inequality in Early Breast Cancer
| NCT ID | NCT07007169 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Esbjerg Hospital - University Hospital of Southern Denmark |
| Condition | Early Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 105 participants |
| Start Date | 2025-03-27 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 105 participants in total. It began in 2025-03-27 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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. \- 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07007169 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Early Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07007169 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07007169 currently recruiting?
Yes, NCT07007169 is actively recruiting participants. Contact the research team at fdonskov@health.sdu.dk for enrollment information.
Where is the NCT07007169 trial being conducted?
This trial is being conducted at Esbjerg, Denmark, Vejle, Denmark.
Who is sponsoring the NCT07007169 clinical trial?
NCT07007169 is sponsored by Esbjerg Hospital - University Hospital of Southern Denmark. The trial plans to enroll 105 participants.
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