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:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT07132034
Eligibility Criteria:
Inclusion criteria:
* Patients with localized breast cancer having completed primary therapy (operation +/- chemotherapy +/- radiotherapy) in the last 6 months - Distress Thermometer ≥ 5 - Age ≥ 18 years - Signed informed consent for participation of the trial
* Prior cancer is allowed
* Prior treatment - including chemotherapy - for a prior malignant tumor (including breast cancer) is allowed
* Concomitant participation in an experimental therapeutic drug trial is allowed
* Ongoing or planned Anti-her2/neu, immune checkpoint inhibitor, antihormonal and CDK4/6 inhibitor therapy or other adjuvant treatment scheduled for \> 3 months during study period is allowed
* Use of other complementary methods (including mistletoe) is allowed.
Exclusion criteria:
* Patients with language or cognitive deficits (including impaired consciousness) that are incompatible with the participation in the study
* Severe physical or psychiatric comorbidity that prevents a patient from participating in the study
* Patients incapable of giving consent
* Pregnancy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07132034
Study Brief:
Protocol Section:
NCT07132034