Plant-derived Nutrients in the Prevention and Prognosis of Breast Cancer in Women.

NCT07868159 | Active Not Recruiting

• 1 other identifier: BCR2025-03
• Study Type: interventional
• Target: 639
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

nutrient

Outcome Measures

Primary Outcomes (1)

• Changes in serum levels of interferon-γ (IFN-γ), tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6) over 12 weeks

  24month

Study Arms (1)

plant-derived nutrients

EXPERIMENTAL

Dietary Supplement: Curcumin

Interventions

Curcumin DIETARY_SUPPLEMENT

curcumin together with othe plant-derived nutrients

plant-derived nutrients

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• 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;

Sponsors & Collaborators

• Keda Yu: lead

Study Sites (1)

Shanghai Cancer Hospital, Fudan University

Shanghai, Xuhui, 200032, China

Location

Related Publications (16)

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• Iwase S, Kawaguchi T, Yotsumoto D, Doi T, Miyara K, Odagiri H, Kitamura K, Ariyoshi K, Miyaji T, Ishiki H, Inoue K, Tsutsumi C, Sagara Y, Yamaguchi T. Efficacy and safety of an amino acid jelly containing coenzyme Q10 and L-carnitine in controlling fatigue in breast cancer patients receiving chemotherapy: a multi-institutional, randomized, exploratory trial (JORTC-CAM01). Support Care Cancer. 2016 Feb;24(2):637-646. doi: 10.1007/s00520-015-2824-4. Epub 2015 Jun 24.

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

Curcumin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director,Department of Breast Surgery,Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: October 9, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2034
• Last Updated: October 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)