An interventional study of Curcumin in Breast Cancer, sponsored by Keda Yu. Active, not recruiting at 1 site in China. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Keda Yu · Not applicable, Interventional, and Prevention
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.
Breast cancer is the most common malignant tumor among women worldwide, with a new case diagnosed every 1.8 seconds on average ; in 2020, it surpassed lung cancer to become the most prevalent cancer globally. In my country, the incidence of breast cancer has risen year by year alongside lifestyle changes; in 2020, there were 416,000 new cases, accounting for 9.1% of all new cancer diagnoses and 19.9% of new cancer cases among women, making it the most common cancer among Chinese women . Concurrently with the rising incidence, the mortality rate of breast cancer in my country has also increased annually, rising from 4.87 per 100,000 in 2003 and 6.67 per 100,000 in 2015 to 9.50 per 100,000 in 2020 . Despite continuous advancements in treatments such as surgery, chemotherapy, and targeted therapy, issues such as recurrence, metastasis, and treatment-related side effects continue to severely compromise patients' quality of life . Among high-risk populations, factors such as genetics (e.g., BRCA mutations), hormonal exposure, and lifestyle choices collectively drive the risk of developing the disease; consequently, there is an urgent need for effective preventive measures to reduce incidence, as well as innovative strategies to improve patient prognosis and alleviate the disease burden.
Dietary nutrition is a key modifiable factor in the primary prevention and rehabilitation management of breast cancer. Researchers have found that the Mediterranean diet can significantly improve inflammatory and immune markers, including interferon-gamma (IFN-γ), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α) . Studies indicate that bioactive compounds derived from plants influence the onset and progression of breast cancer through mechanisms such as antioxidant activity, anti-inflammatory effects, and epigenetic regulation . For instance, coenzyme Q10 can inhibit tumor growth, enhance the efficacy of endocrine therapy for breast cancer, and alleviate chemotherapy-induced side effects ; resveratrol reduces the release of inflammatory cytokines by inhibiting the NF-κB pathway, and studies indicate an inverse correlation between resveratrol intake and breast cancer risk ; anthocyanins modulate the activity of estrogen-metabolizing enzymes and inhibit the proliferation of hormone-dependent tumors ; curcumin blocks the Wnt/β-catenin signaling pathway, thereby inhibiting the invasion and metastasis of triple-negative breast cancer ; and ginsenosides exert synergistic anti-tumor effects by activating immune cells and inducing apoptosis in tumor cells . The multi-target nature of these natural compounds offers new perspectives for breast cancer prevention and treatment, yet their clinical translation requires support from high-quality evidence.
Current research largely focuses on single compounds in laboratory settings or small-scale clinical trials, which fail to capture the complexities of human metabolism and the synergistic effects of multiple components in real-world scenarios. Furthermore, the long-term effects, dose-dependency, and impact of population heterogeneity (such as molecular subtypes and genetic polymorphisms) regarding nutritional interventions remain unclear. While the strictly controlled conditions of traditional randomized controlled trials (RCTs) can validate efficacy, extrapolating results to real-world populations is often complicated by confounding factors like concomitant medications and dietary variations. Therefore, integrating multi-center real-world data to systematically evaluate the value of phytonutrient supplements in prevention and prognosis represents a crucial pathway to bridging the translational medicine gap.
This study aims to conduct a multi-center real-world study comprising a "prevention cohort" and a "prognosis cohort." The prevention cohort targets individuals at high risk for breast cancer to evaluate the inhibitory effects of plant-derived nutrients-such as curcumin and anthocyanins-on precancerous lesions. The prognosis cohort, stratified by breast cancer molecular subtypes, will investigate the effects of subtype-specific plant-derived nutritional interventions on patient constitution, inflammatory-immune status, survival outcomes, and quality of life. Through dynamic follow-up, biomarker analysis, and real-world efficacy comparisons, the study seeks to establish personalized nutritional intervention strategies and provide evidence-based support for breast cancer prevention and treatment.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 639 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Keda Yu is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
predictive cohort
Inclusion Criteria:
Exclusion Criteria:
prognostic cohort
Inclusion Criteria:
Female, aged 18-65, with an expected lifespan of ≥5 years;
Exclusion Criteria:
Dietary Supplement: Curcumin
curcumin together with othe plant-derived nutrients
Changes in serum levels of interferon-γ (IFN-γ), tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6) over 12 weeks
Time frame: 24month
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Started Aug 2026 (actual). Primary completion is estimated for Sep 2027, 13 months after the start.
Of 2,272 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's planned 13 months is below that.
Counting every sponsor, half of 2,345 studies reached it within 34 months; a quarter within 16 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Curcumin
Keda Yu