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Active Not Recruiting
NCT07868159
Plant-derived Nutrients in the Prevention and Prognosis of Breast Cancer in Women.
Conditions: Breast Cancer
Sex: Female
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 639
Sponsor: Keda Yu
Location: Shanghai Cancer Hospital, Fudan University Shanghai Xuhui
Summary
This study evaluates the impact of plant-derived nutritional interventions on inflammation, immune function-related indicators, and quality of life in healthy women and breast cancer patients based on real-world data, providing evidence for the prevention and treatment of breast cancer.
Eligibility Criteria
predictive cohort
Inclusion Criteria:
* Female, aged 18-65 years, with an expected lifespan of ≥5 years;
* Meets the definition of high risk for breast cancer (fulfills at least one criterion): carrier of BRCA1/2 mutations, family history of breast cancer in first-degree relatives, confirmed atypical ductal hyperplasia (ADH/LCIS) through breast biopsy, mammography indicating high glandular density, or previous chest radiotherapy before the age of 30.
Exclusion Criteria:
* Previous history of breast cancer or other malignant tumors; pregnancy or lactation;
* Currently using hormone replacement therapy (HRT) or prophylactic tamoxifen; Abnormal liver and kidney function (ALT/AST \>2 times the upper limit, Cr \>1.5 mg/dL);
* Allergic to the components of the sample;
* The patient has poor cognitive ability and is unable to answer questions or fill out questionnaires;
* The researcher believes that it is not suitable for him/her to participate in this study.
prognostic cohort
Inclusion Criteria:
Female, aged 18-65, with an expected lifespan of ≥5 years;
* Pathologically diagnosed as invasive breast cancer with clear molecular typing (ER-positive, HER2-positive, or triple-negative);
* Has completed radical treatment for breast cancer during the intensive phase, with no known residual lesions.
Exclusion Criteria:
* Presence of distant metastasis (stage IV) or local recurrence;
* Is currently undergoing chemotherapy, immunotherapy, or experimental drugs (excluding endocrine/targeted therapy);
* Plan to undergo major surgery or radiotherapy within the next 6 months;
* Pregnancy or lactation; Abnormal liver and kidney function (ALT/AST \>2 times the upper limit, Cr \>1.5 mg/dL);
* Allergic to the components of the sample;
* The patient has poor cognitive ability and is unable to answer questions or fill out questionnaires;
* The researcher deems himself/herself unsuitable for participation in this study.
Source: ClinicalTrials.gov (NCT07868159). StuddyBuddy aggregates publicly available trial information.