Clinical trial · Interventional
Effect of Resveratrol on Serum IGF2 Among African American Women
Mechanisms in IGF2 Induced Chemoresistance and Mitochondrial Regulation in Triple Negative Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to COVID-19
Summary
Brief summary (as posted)
African American (AA) women with breast cancer (BC) have higher mortality and are associated with worse outcomes when treated with available adjuvant treatments. Addressing this survival disparity will depend on identifying contributing biologic factors that can be translated into new treatments. Preclinical studies have shown that Insulin-like growth factor-II (IGF-II)expression was significantly higher in AA cell lines and tissue samples when compared to Caucasians indicating that IGF-II is an important biologic factor contributing to higher breast cancer mortality in AA women and is also responsible for chemoresistance in BC cells. In addition preclinical studies also demonstrated that resveratrol (RSV) inhibits IGF-II and induces apoptosis in BC cell lines. Researchers want to test IGF-II levels at baseline in healthy African American women and monitor levels while on resveratrol therapy for 6 weeks.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemoprevention | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Resveratrol (RSV) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- description
- Participants with receive resveratrol at 150 mg daily for 6 weeks
- interventionNames
- Dietary Supplement: Resveratrol (RSV)
Primary outcomes (1)
- measure
- IGF2 assessment by Elisa assays
- timeFrame
- Week 0, 2, 4 6
- description
- To determine changes in the levels of IGF-II (mIGF2 or Pro-IGF2)
Secondary outcomes (1)
- measure
- IGFBP-3 assessment by Elisa assays
- timeFrame
- Week 0, 2, 4, 6
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA * African American ethnicity self-identified * Female participants aged 18 years and above * Able to provide written informed consent and to understand, participate and comply with protocol requirements * Able to comprehend and complete forms in English * Able to swallow oral capsules * Willingness to stop dietary supplements and vitamins for the duration of the study * No history of cancers in the past 5 years * Willingness to abstain from ingestion of large quantities of RSV containing foods and less than 3 drinks of wine per week. EXCLUSION CRITERIA * Pregnant or planning to be pregnant or breast feeding * Participating in any other clinical study * History of Diabetes defined as recent A1C greater than 6.5 and or fasting serum glucose greater than or equal to 126 mg/dl * Self-reported history of major organ dysfunction (renal dysfunction described as glomerular filtration rate (GFR) less than 60 ml/min, liver function tests greater than 2 times normal) * Patients on below medications due to potential interactions * Cholesterol medications Atorvastatin (Lipitor), Rosuvastatin (Crestor), Simvastatin (Zocor), Gemfibrozil (Lopid), Niacin (Niacor), etc. * Aspirin greater than 81 mg. Taking medicines that may increase the risk of bleeding such as Coumadin (warfarin), Plavix (clopidogrel), Xarelto (rivaroxaban), Pradaxa (dabigatran), Eliquis (apixaban) or Heparin (blood thinning medications) due to their potential interaction with resveratrol * Chronic (daily) use of non-steroidal anti-inflammatory agents (NSAIDs) such as Motrin (Ibuprofen), Advil (Ibuprofen) or Naprosyn (Naproxen) due to potential interaction with resveratrol. (Occasional use is ok). Anti-diabetic medications: Insulin, Metformin (Glucophage, Avandamet, Glibomet, etc), Rosiglitazone (Avandia), Exenatide (Byetta), Sitagliptin (Januvia), etc. Anti-hypertensive medications Metoprolol (Lopressor), Carvedilol (Coreg), Nifedipine (Procardia, Adalat), Verapamil (Verelan,Calan, Covera), Lisinopril (Prinivil, Zestril), Captopril (Capoten), Losartan (Cozaar), Irbesartan (Avapro), etc. Testosterone and estrogen supplement. Current glucocorticoid use, or up to 3 months ago (nasal, topical, ophthalmic, and inhaled use are not exclusionary) * Participants with other major uncontrolled medical problems or, at the discretion of the PI, Participants on other long term prescription medications for chronic illness * At the discretion of the investigators if considered unfit for the study based on medical or psycho-social conditions * Non-English speaking participants
References
Publications (0)
Data not yet available