ChemopreventionNCT04266353
Effect of Resveratrol on Serum IGF2 Among African American Women
A study testing Resveratrol (RSV) in people with Chemoprevention, run by Loma Linda University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chemoprevention
- What is being tested?
- Resveratrol (RSV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2019to 22 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Cancer Center
Loma Linda, California, 92350
About this study
Official title: Mechanisms in IGF2 Induced Chemoresistance and Mitochondrial Regulation in Triple Negative Breast Cancer
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.
Read the detailed description
Resveratrol (RSV) is a naturally occurring polyphenol found in many plants including grapes, peanuts and berries. Resveratrol has attracted a lot of research attention based on preclinical data showing anti-inflammatory and anti-oxidative properties through several mechanisms.RSV is available as over the counter supplement in the United States. Various formulations and dosage forms have been used in previous studies involving cardiovascular health, metabolism and chemoprevention. ResVida®, is an oral preparation consisting of pure trans-resveratrol with a purity of > 99% manufactured by DSM nutritional products will be used in this study. Healthy African American women will receive 1 capsule daily of 150 mg.
Objectives: To test the effects of resveratrol on IGF-II level in healthy AA women.
Eligibility: Healthy adult African American female (18 years of age or older) Design: The study involves an initial visit and 3 additional visits at 2 week interval. At the initial visit, women will participate in a short-talk session to present the study, facts about breast cancer, RSV and protocol requirements. Participants will be evaluated for meeting basic eligibility criteria by a Breast Oncologist. All interested participants will sign an informed consent form and will be provided with a questionnaire to complete. The Oncologist will obtain medical history, use of medication, supplements etc. from consented participants. Consented participants will then meet with the study coordinator who will assign each participant with a study identification (ID) number along with other basic assessment as noted below. The study coordinator will also dispense a 2 week supply of RSV along with a medication calendar to each participant at their initial visit and at visits 2-4. In addition, the participants will have their blood sample collected by a trained phlebotomist during visit 1 and at visits 2-4. Collected blood vials will be handed to research laboratory to determine IGF2 levels as well as other research biomarkers.
- Conditions
- Chemoprevention
- Being tested
- Resveratrol (RSV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resveratrol (RSV)Dietary supplement
Also called ResVida
Participants will receive Resveratrol at 150 mg daily for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Participants with receive resveratrol at 150 mg daily for 6 weeks Receives: Dietary Supplement: Resveratrol (RSV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IGF2 assessment by Elisa assays
To determine changes in the levels of IGF-II (mIGF2 or Pro-IGF2)
Measured: Week 0, 2, 4 6
Secondary outcomes (1)
IGFBP-3 assessment by Elisa assays
To determine changes in the levels of IGFBP-3 levels
Measured: Week 0, 2, 4, 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start24 Apr 2019
- Primary completion22 Aug 2022
- Study completion22 Aug 2022
Why it stopped: Due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChemopreventionStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gayathri Nagaraj, Loma Linda University
- Investigators
- Gayathri Nagaraj, MD, Principal investigator, Loma Linda University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266353
- Sponsor's protocol ID
- 5160378
- Status last verified
- May 2023
- First submitted
- 27 Jan 2020
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms in IGF2 Induced Chemoresistance and Mitochondrial Regulation in Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT04266353
- Acronym / sponsor ID
- 5160378
- Conditions
- Chemoprevention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Resveratrol (RSV) is a naturally occurring polyphenol found in many plants including grapes, peanuts and berries. Resveratrol has attracted a lot of research attention based on preclinical data showing anti-inflammatory and anti-oxidative properties through several mechanisms.RSV is available as over the counter supplement in the United States. Various formulations and dosage forms have been used in previous studies involving cardiovascular health, metabolism and chemoprevention. ResVida®, is an oral preparation consisting of pure trans-resveratrol with a purity of > 99% manufactured by DSM nutritional products will be used in this study. Healthy African American women will receive 1 capsule daily of 150 mg.
Objectives: To test the effects of resveratrol on IGF-II level in healthy AA women.
Eligibility: Healthy adult African American female (18 years of age or older) Design: The study involves an initial visit and 3 additional visits at 2 week interval. At the initial visit, women will participate in a short-talk session to present the study, facts about breast cancer, RSV and protocol requirements. Participants will be evaluated for meeting basic eligibility criteria by a Breast Oncologist. All interested participants will sign an informed consent form and will be provided with a questionnaire to complete. The Oncologist will obtain medical history, use of medication, supplements etc. from consented participants. Consented participants will then meet with the study coordinator who will assign each participant with a study identification (ID) number along with other basic assessment as noted below. The study coordinator will also dispense a 2 week supply of RSV along with a medication calendar to each participant at their initial visit and at visits 2-4. In addition, the participants will have their blood sample collected by a trained phlebotomist during visit 1 and at visits 2-4. Collected blood vials will be handed to research laboratory to determine IGF2 levels as well as other research biomarkers.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Dietary Supplement: Resveratrol (RSV)Participants with receive resveratrol at 150 mg daily for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resveratrol (RSV)Also: ResVidaParticipants will receive Resveratrol at 150 mg daily for 6 weeks. | Dietary supplement | Single arm |
Primary outcome
IGF2 assessment by Elisa assays
Time frame: Week 0, 2, 4 6
To determine changes in the levels of IGF-II (mIGF2 or Pro-IGF2)
1 secondary outcome
IGFBP-3 assessment by Elisa assays
Time frame: Week 0, 2, 4, 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: No
Related trials for Chemoprevention
Recruiting
Decision Support for Chemoprevention
Breast Cancer
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
RecruitingPhase 1
Testing for Safety and Colorectal Cancer Preventive Effects of ONC201
Colorectal Adenomatous Polyp, Colorectal Carcinoma
RecruitingPhase 2
Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia
RecruitingPhase 3
Nicotinamide Chemoprevention for Keratinocyte Carcinoma in Solid Organ Transplant Recipients - Pivotal Trial
Non-melanoma Skin Cancer, Carcinoma, Squamous Cell
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gayathri Nagaraj, MD principal investigator
Loma Linda University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resveratrol (RSV) in people with Chemoprevention, run by Loma Linda University at 1 site in United States.
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 8 inclusion and 11 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: withdrawn, as of the sponsor's last update on 9 May 2023. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
IGF2 assessment by Elisa assays (time frame: Week 0, 2, 4 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2023.