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Breast CancerPlantNCT07868159

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

A study testing Curcumin in people with Breast Cancer, run by Keda Yu at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
Curcumin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
639 participants
Where
1 siteChina
Study dates
1 Aug 2026to 1 Sep 2034
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Shanghai Cancer Hospital, Fudan University

    Shanghai, Xuhui, 200032

Other trials in China

About this study

Official title: A Single-arm, Multicenter, Real-world Study on the Combined Application of Plant-derived Nutrients in the Prevention and Prognosis of Breast Cancer in Women.

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.

Read the detailed description

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.

Conditions
Breast Cancer
Being tested
Curcumin
Keywords
nutrient
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CurcuminDietary supplement

    curcumin together with othe plant-derived nutrients

Study groups in NCT07868159
Study groupRoleWhat they receive
plant-derived nutrientsExperimentalNot described
Receives: Dietary Supplement: Curcumin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 24month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2026
  2. Study start1 Aug 2026
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 Sep 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
639 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07868159
Sponsor's protocol ID
BCR2025-03
Acronym
Plant
Status last verified
Sep 2026
First submitted
17 Aug 2026
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhu Y, Wang A, Zhang S, Kim J, Xia J, Zhang F, Wang D, Wang Q, Wang J. Paclitaxel-loaded ginsenoside Rg3 liposomes for drug-resistant cancer therapy by dual targeting of the tumor microenvironment and cancer cells. J Adv Res. 2023 Jul;49:159-173. doi: 10.1016/j.jare.2022.09.007. Epub 2022 Sep 24.

    PubMed 36167294
  • Peng B, He R, Xu Q, Yang Y, Hu Q, Hou H, Liu X, Li J. Ginsenoside 20(S)-protopanaxadiol inhibits triple-negative breast cancer metastasis in vivo by targeting EGFR-mediated MAPK pathway. Pharmacol Res. 2019 Apr;142:1-13. doi: 10.1016/j.phrs.2019.02.003. Epub 2019 Feb 5.

    PubMed 30735802
  • Hamidian M, Foroughinia F, Haghighat S, Attar A, Haem E. Protective effects of Panax ginseng against doxorubicin-induced cardiac toxicity in patients with non-metastatic breast cancer: A randomized, double-blind, placebo-controlled clinical trial. J Oncol Pharm Pract. 2023 Sep;29(6):1306-1316. doi: 10.1177/10781552221118530. Epub 2022 Aug 17.

    PubMed 35975564
  • Narasimhan M, Ammanamanchi S. Curcumin blocks RON tyrosine kinase-mediated invasion of breast carcinoma cells. Cancer Res. 2008 Jul 1;68(13):5185-92. doi: 10.1158/0008-5472.CAN-07-6883.

    PubMed 18593918
  • Saghatelyan T, Tananyan A, Janoyan N, Tadevosyan A, Petrosyan H, Hovhannisyan A, Hayrapetyan L, Arustamyan M, Arnhold J, Rotmann AR, Hovhannisyan A, Panossian A. Efficacy and safety of curcumin in combination with paclitaxel in patients with advanced, metastatic breast cancer: A comparative, randomized, double-blind, placebo-controlled clinical trial. Phytomedicine. 2020 Apr 15;70:153218. doi: 10.1016/j.phymed.2020.153218. Epub 2020 Apr 18.

    PubMed 32335356
  • Touvier M, Druesne-Pecollo N, Kesse-Guyot E, Andreeva VA, Fezeu L, Galan P, Hercberg S, Latino-Martel P. Dual association between polyphenol intake and breast cancer risk according to alcohol consumption level: a prospective cohort study. Breast Cancer Res Treat. 2013 Jan;137(1):225-36. doi: 10.1007/s10549-012-2323-y. Epub 2012 Nov 7.

    PubMed 23132534
  • Scarlatti F, Maffei R, Beau I, Codogno P, Ghidoni R. Role of non-canonical Beclin 1-independent autophagy in cell death induced by resveratrol in human breast cancer cells. Cell Death Differ. 2008 Aug;15(8):1318-29. doi: 10.1038/cdd.2008.51. Epub 2008 Apr 18.

    PubMed 18421301
  • Levi F, Pasche C, Lucchini F, Ghidoni R, Ferraroni M, La Vecchia C. Resveratrol and breast cancer risk. Eur J Cancer Prev. 2005 Apr;14(2):139-42. doi: 10.1097/00008469-200504000-00009.

    PubMed 15785317
  • Tosi G, Paoli A, Zuccolotto G, Turco E, Simonato M, Tosoni D, Tucci F, Lugato P, Giomo M, Elvassore N, Rosato A, Cogo P, Pece S, Santoro MM. Cancer cell stiffening via CoQ10 and UBIAD1 regulates ECM signaling and ferroptosis in breast cancer. Nat Commun. 2024 Sep 18;15(1):8214. doi: 10.1038/s41467-024-52523-y.

    PubMed 39294175
  • 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.

    PubMed 26105516
  • Samanta SK, Choudhury P, Sarma PP, Gogoi B, Gogoi N, Devi R. Dietary phytochemicals/nutrients as promising protector of breast cancer development: a comprehensive analysis. Pharmacol Rep. 2022 Aug;74(4):583-601. doi: 10.1007/s43440-022-00373-0. Epub 2022 Jun 4.

    PubMed 35661126
  • Bagheri A, Asoudeh F, Rezaei S, Babaei M, Esmaillzadeh A. The Effect of Mediterranean Diet on Body Composition, Inflammatory Factors, and Nutritional Status in Patients with Cachexia Induced by Colorectal Cancer: A Randomized Clinical Trial. Integr Cancer Ther. 2023 Jan-Dec;22:15347354231195322. doi: 10.1177/15347354231195322.

    PubMed 37621140
  • Barzaman K, Karami J, Zarei Z, Hosseinzadeh A, Kazemi MH, Moradi-Kalbolandi S, Safari E, Farahmand L. Breast cancer: Biology, biomarkers, and treatments. Int Immunopharmacol. 2020 Jul;84:106535. doi: 10.1016/j.intimp.2020.106535. Epub 2020 Apr 29.

    PubMed 32361569
  • Kim J, Harper A, McCormack V, Sung H, Houssami N, Morgan E, Mutebi M, Garvey G, Soerjomataram I, Fidler-Benaoudia MM. Global patterns and trends in breast cancer incidence and mortality across 185 countries. Nat Med. 2025 Apr;31(4):1154-1162. doi: 10.1038/s41591-025-03502-3. Epub 2025 Feb 24.

    PubMed 39994475
  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

Questions about this trial

What is this clinical trial studying?

A study testing Curcumin in people with Breast Cancer, run by Keda Yu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07868159, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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