NCT00566553

Brief Summary

The role of estrogens in the pathogenesis of breast cancer has been well documented. This has led to the development of "Anti-Estrogens" (selective estrogens receptor modulators and Aromatase Inhibitors), used for treatment and prevention of breast cancer. These agents, however, have significant side effects, which are not acceptable to many healthy high-risk women. There is preliminary evidence that grape seed extract acts as "natural" aromatase inhibitor (1). This study has the potential to quantify the effectiveness of a natural substance that mimics the action of pharmaceutical aromatase inhibitors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2008

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 3, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

January 6, 2012

Status Verified

January 1, 2012

Enrollment Period

3.6 years

First QC Date

November 30, 2007

Last Update Submit

January 4, 2012

Conditions

Breast Cancer

Keywords

Grape Seed ExtractBreast CancerEstrogen LevelsAromatase Inhibitor

Outcome Measures

Primary Outcomes (1)

  • To document that grape seed extract taken orally will decrease plasma estrogen levels (estrone (E1), estradiol (E2), and E1-conjugates) and increase precursor androgen levels (testosterone and androstenedione) in healthy postmenopausal women.

    12 weeks

Secondary Outcomes (1)

  • To determine the most effective, well tolerated dose of grape seed extract resulting in a decrease in plasma estrogen levels (E1, E2, E1-conjugates) and increase in precursor androgens (testosterone and androstenedione).

    12 weeks

Study Arms (4)

Grape Seed Extract # 1

ACTIVE COMPARATOR

200 mg \[1 pill\]

Dietary Supplement: Grape Seed Extract

Grape Seed Extract # 2

ACTIVE COMPARATOR

200 mg \[2 pills\]

Dietary Supplement: Grape Seed Extract

Grape Seed Extract # 3

ACTIVE COMPARATOR

200 mg \[3 pills\]

Dietary Supplement: Grape Seed Extract

Grape Seed Extract # 4

ACTIVE COMPARATOR

200 mg \[4 pills\]

Dietary Supplement: Grape Seed Extract

Interventions

Grape Seed ExtractDIETARY_SUPPLEMENT

200 mg dose daily for 12 weeks.

Also known as: ActiVin®
Grape Seed Extract # 1

Eligibility Criteria

Age55 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 55 - 75 years
  • Able to understand and sign a consent form
  • Postmenopausal (no menstrual period for 1 year or more)
  • No personal cancer history (except for non-melanoma skin cancer)
  • No hormone replacement therapy or anti-estrogens within 6 months of baseline

You may not qualify if:

  • Known allergy to grapes or grape products
  • Currently on ACE inhibitors, methotrexate, allopurinol, coumadin (Warfarin, Jantoven), heparin, clopidogrel (Plavix), or cholesterol lowering medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

  • Eng ET, Ye J, Williams D, Phung S, Moore RE, Young MK, Gruntmanis U, Braunstein G, Chen S. Suppression of estrogen biosynthesis by procyanidin dimers in red wine and grape seeds. Cancer Res. 2003 Dec 1;63(23):8516-22.

    PMID: 14679019BACKGROUND

  • American Cancer Society. Cancer Facts and Figures 2005. Atlanta, GA: American Cancer Society; 2005.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Grape Seed ExtractActivins

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex MixturesPharmaceutical PreparationsGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptide HormonesGlycoproteinsGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and ProteinsProteins

Study Officials

  • Dietlind L. Wahner-Roedler, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 30, 2007

First Posted

December 3, 2007

Study Start

February 1, 2008

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

January 6, 2012

Record last verified: 2012-01

Locations

US(1)