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AGE Levels in ER+ Metastatic Breast Cancer Patients Receiving Endocrine Therapy

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ClinicalTrials.gov Identifier: NCT03092635
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:
The purpose of this study is to look at the effects that the study drug (OPC) has on AGE levels in patients with ER+ metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: OPC Phase 1

Detailed Description:
AGEs are a type of metabolite, or substance, found in the food. The AGE content in food is determined by the types of food you eat and also how you prepare your food. The researchers helping conduct this study have found a potential link between AGE levels and cancer. The purpose of this study is to see if certain drug (OPC) has an effect on the AGE levels in your blood and to see if those AGE levels have an effect on your cancer.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in ER+, Metastatic Breast Cancer Patients Receiving Endocrine Therapy
Actual Study Start Date : June 6, 2017
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: OPC
During weeks 1- 12, subjects will take one OPC tablet in the morning and in the evening, about 12 hours apart.
Drug: OPC
OPC is a derivative of grape seed extract




Primary Outcome Measures :
  1. AGE level reduction [ Time Frame: 85 days ]
    The primary objective is to determine if the test agents are able to reduce AGE levels by at least 30% in th 50% or more of test subjects.


Secondary Outcome Measures :
  1. Correlation between AGE level and changes to BMI [ Time Frame: 85 days ]
    Changes in AGE levels and BMI will be described using graphs and other models.

  2. Correlation between AGE level and insulin resistance (HOMA-IR) [ Time Frame: 85 days ]
    Changes in AGE levels and HOMA-IR will be described using graphs and other models.

  3. Correlation between AGE level and A1C [ Time Frame: 85 days ]
    Changes in AGE levels and A1C will be described using graphs and other models.

  4. Correlation between AGE level and lipids [ Time Frame: 85 days ]
    Changes in AGE levels and lipids will be described using graphs and other models.

  5. Correlation between AGE level and diet [ Time Frame: 85 days ]
    Changes in AGE levels and diet will be described using graphs and other models. Diet will be assessed by using the NIH "Eating at America's Table Study Quick Food Scan" and the NCI "Quick Food Scan"

  6. Correlation between AGE level and quality of life [ Time Frame: 85 days ]
    Measured by FACT-B quality of life questionnaire

  7. Correlation between AGE level and plasma IL6 [ Time Frame: 85 days ]
    Changes in AGE levels and IL6 will be described using graphs and other models.

  8. Correlation between AGE level and leptin [ Time Frame: 85 days ]
    Changes in AGE levels and leptin will be described using graphs and other models.

  9. Correlation between AGE level and c-reactive protein (CRP) [ Time Frame: 85 days ]
    Changes in AGE levels and CRP will be described using graphs and other models.

  10. Correlation between AGE level and malondialdehyde (MDA) [ Time Frame: 85 days ]
    Changes in AGE levels and MDA will be described using graphs and other models.

  11. Correlation between AGE level and oxLDLs (low density lipoprotein) [ Time Frame: 85 days ]
    Changes in AGE levels and oxLDLs will be described using graphs and other models.

  12. Correlation between AGE level and sRAGE (soluble receptor for AGE) [ Time Frame: 85 days ]
    Changes in AGE levels and sRAGE will be described using graphs and other models.

  13. Frequency of adverse events as assessed by CTCAE v. 4 [ Time Frame: 85 days ]
    Toxicities will be tabulated by type, grade and the visit at which they occurred.

  14. Tumor response to treatment as assessed by RECIST 1.1 or MD Anderson criteria [ Time Frame: 85 days ]
    The anti-tumor response will be measured by comparing baseline and post-treatment imaging using RECIST 1.1 or MD Anderson criteria for bone only disease.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have ER+ breast cancer
  • Metastatic disease; protocol does allow for bone-only disease
  • Must be receiving endocrine therapy
  • Must have completed at last 2 months of current endocrine therapy prior to registration
  • Must have adequate hematologic, renal and hepatic function
  • Prior/concurrent radiation therapy is allowed
  • Prior chemotherapy is allowed, but last dose must have been at least 2 months prior to enrollment
  • May have diabetes, but must not be taking metformin
  • Must be able to swallow and retain oral medication
  • Performance status of 0-2
  • Treated stable brain metastases are allowed, as long as patient does not require steroids or anti-seizure medications
  • Must be informed of the investigational nature of this study and must have the ability to sign informed consent.

Exclusion Criteria:

  • Known allergy to grapes or grape seed
  • More than two prior endocrine therapy regimens for the treatment of metastatic ER+ breast cancer.
  • Concurrent use of restricted agents outlined in section 4.5.
  • History of alcohol abuse within 2 years of registration.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092635


Contacts
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Contact: Vistea Crawford 843-792-9321 hcc-cto-clinops@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Vistea Crawford    843-792-9321    hcc-clinical-trials@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Antonio Giordano, MD Medical University of South Carolina

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03092635     History of Changes
Other Study ID Numbers: 102560
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases