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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 : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE March 22, 2017
First Posted Date  ICMJE March 28, 2017
Last Update Posted Date October 2, 2019
Actual Study Start Date  ICMJE June 6, 2017
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03092635 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2017)
  • 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.
  • 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.
  • Correlation between AGE level and A1C [ Time Frame: 85 days ]
    Changes in AGE levels and A1C will be described using graphs and other models.
  • Correlation between AGE level and lipids [ Time Frame: 85 days ]
    Changes in AGE levels and lipids will be described using graphs and other models.
  • 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"
  • Correlation between AGE level and quality of life [ Time Frame: 85 days ]
    Measured by FACT-B quality of life questionnaire
  • 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.
  • Correlation between AGE level and leptin [ Time Frame: 85 days ]
    Changes in AGE levels and leptin will be described using graphs and other models.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AGE Levels in ER+ Metastatic Breast Cancer Patients Receiving Endocrine Therapy
Official Title  ICMJE Pilot Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in ER+, Metastatic Breast Cancer Patients Receiving Endocrine Therapy
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: OPC
OPC is a derivative of grape seed extract
Study Arms  ICMJE Experimental: OPC
During weeks 1- 12, subjects will take one OPC tablet in the morning and in the evening, about 12 hours apart.
Intervention: Drug: OPC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 22, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vistea Crawford 843-792-9321 hcc-cto-clinops@musc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03092635
Other Study ID Numbers  ICMJE 102560
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Antonio Giordano, MD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP