Mediterranean Diet and Inequality in Early Breast Cancer

NCT07007169 | Recruiting Phase 2

• 1 other identifier: 629752-24 S-20240087
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

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.

Conditions

Early Breast Cancer

Keywords

Microbiome; Mediterranean Diet; Inequality in cancer; Chemotherapy; Adjuvant; Neoadjuvant; Short-chain Fatty Acids

Outcome Measures

Primary Outcomes (1)

• Change in microbiota composition

  The primary objective of this trial, assessing the clinical efficacy of the Mediterranean diet, is changes in gut microbiota composition, analyzed as microbial differential abundance (measures the difference in the abundance of specific microbial taxa between groups) by the ZicoSeq differential abundance analysis method, accounting for multiple-testing using the false discovery method (FDR). The endpoint will be measured at cycle 6 and compared with baseline values, in patients allocated to the Mediterranean Diet compared to patients on their regular diet.

  Baseline to Day 1 of chemotherapy cycle 6. Each cycle is 3 weeks for regular schedule or 2 weeks for accelerated schedule, as per clinician decision.

Secondary Outcomes (9)

• Change in alpha diversity in stool samples

  Baseline to Day 1 of chemotherapy cycle 6. Each cycle is 3 weeks for regular schedule or 2 weeks for accelerated schedule, as per clinician decision.

• Change in beta diversity in stool samples

  Baseline to Day 1 of chemotherapy cycle 6. Each cycle is 3 weeks for regular schedule or 2 weeks for accelerated schedule, as per clinician decision.

• Level of short-chain fatty acids in stool and plasma

  Baseline to Day 1 of chemotherapy cycle 6. Each cycle is 3 weeks for regular schedule or 2 weeks for accelerated schedule, as per clinician decision.

• Quality of life measured by WHOQOL-questionnaire

  Baseline to Day 1 of chemotherapy cycle 6. Each cycle is 3 weeks for regular schedule or 2 weeks for accelerated schedule, as per clinician decision.

• Socioeconomic factors and quality of life correlated with microbiome composition and diversity

  Baseline to Day 1 of chemotherapy cycle 6. Each cycle is 3 weeks for regular schedule or 2 weeks for accelerated schedule, as per clinician decision.

Other Outcomes (15)

• Level of CD4+ T-cell immune activity in blood

  Baseline to Day 1 of chemotherapy cycle 6. Each cycle is 3 weeks for regular schedule or 2 weeks for accelerated schedule, as per clinician decision.

• Level of CD8+ T-cell immune activity in blood

  Baseline to Day 1 of chemotherapy cycle 6. Each cycle is 3 weeks for regular schedule or 2 weeks for accelerated schedule, as per clinician decision.

• Level of CD 56+ Natural Killer cell immune activity in blood

  Baseline to Day 1 of chemotherapy cycle 6. Each cycle is 3 weeks for regular schedule or 2 weeks for accelerated schedule, as per clinician decision.

Study Arms (2)

Mediterranean Diet

EXPERIMENTAL

The intervention is the Mediterranean Diet.

Dietary Supplement: The 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.

Standard Diet

ACTIVE COMPARATOR

The control group will continue their normal diet.

Other: Standard Diet

Interventions

Standard Diet OTHER

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

Standard Diet

The 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. DIETARY_SUPPLEMENT

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

Mediterranean Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Vejle Hospital: collaborator
• Hospital of Southern Jutland: collaborator
• Odense University Hospital: collaborator
• Esbjerg Hospital - University Hospital of Southern Denmark: lead
• Syddansk Universitet, Denmark: collaborator
• University of Copenhagen: collaborator
• Aarhus University Hospital: collaborator
• Danish Breast Cancer Cooperative Group: collaborator
• Aalborg University: collaborator

Study Sites (2)

University Hospital of Southern Denmark, Esbjerg

Esbjerg, 6700, Denmark

RECRUITING

Sygehus Lillebaelt, Vejle

Vejle, 7100, Denmark

RECRUITING

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Related Links

• Nordic registry of cancer incidences and mortality

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Frede Donskov, Clinical Professor, MD, DMSc,

CONTACT

+45 2053 3235; fdonskov@health.sdu.dk

Lone Gamrath, PhD Fellow

CONTACT

+45 2920 3221; Lone.Gamrath@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized 2:1 to Mediterranean Diet versus standard diet; controlled; blinding is not possible

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: June 5, 2025
• Study Start: March 27, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2036
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: when the clinical trial ends and data are mature, anticipated 1 January 2031
• Access Criteria: Zenodo open data repository (CERN) or other equivalent databases.

Locations

DK (2)