BridgeMD
New treatment option for Early Breast Cancer
Official title Mediterranean Diet and Inequality in Early Breast Cancer
ClinicalTrials.gov ID: NCT07007169
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 18 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join 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...
- Good performance status (WHO performance status 0 or 1).
- Willingness by the patient to undergo treatment and study-related procedures according to the protocol.
You likely can't join 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.
See the full eligibility criteria
- 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...
- 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. \-
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Esbjerg, Denmark
- Vejle, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 18 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Esbjerg, Denmark; Vejle, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.