Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-24 @ 11:09 PM
NCT ID:
NCT07007169
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.
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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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07007169
Study Brief:
Protocol Section:
NCT07007169