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Evaluation of the Aromatase Inhibition Potential of Standardized Grape Extract


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Evaluation of the Aromatase Inhibition Potential of Standardized Grape Extract


OBJECTIVES:

- To measure the change in levels of plasma estrone (E1), estradiol, E1-conjugates, and
E1-sulfates in postmenopausal women after 6 weeks of daily ingestion of 94 grams of
freeze-dried table grape powder.

- To conduct bioavailability research on the freeze-dried table grape powder in humans
through the analysis of participants' blood and urine samples.

OUTLINE: Participants receive oral freeze-dried table grape powder once daily on days 1-42
in addition to their usual diet. Treatment continues in the absence of toxicity.

Participants undergo blood sample collection at baseline, periodically after the first dose,
and on the last day of the study for pharmacokinetic and bioavailability analysis. Samples
are examined by mass spectrometry to measure plasma levels of estrone (E1), estradiol,
E1-conjugates, E1-sulfates, testosterone, and androstenedione. Participants also undergo
spot urine collection and weight and height measurement periodically during study.

Participants complete food diaries on days 1-3, 21-23, and 40-42 to assess their intake of
grapes, grape juice, and red wine and to examine the constancy of their caloric intake over
the course of the study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Participant in the Mayo Mammography Health Study

- Has consented to provide baseline mammogram for digitization

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Female

- Postmenopausal (defined as women who have had both ovaries removed or no menstrual
period for at least 12 consecutive months)

- Able to give informed consent and complete food records alone or with assistance

- Willing to provide research blood and urine samples

- Must be a non-smoker

- Willing to maintain current weight

- No history of breast ductal carcinoma in situ or any other cancer, except basal cell
or squamous cell skin cancer or lobular carcinoma in situ

- No history of allergic or other adverse reaction to grapes

- No history of diabetes or glucose intolerance

PRIOR CONCURRENT THERAPY:

- No concurrent hormone therapy, including estradiol, estrone, or progestins

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Serum levels of plasma estrone (E1), estradiol, E1-conjugates, and E1-sulfates

Safety Issue:

No

Principal Investigator

Janet E. Olson, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000581219

NCT ID:

NCT00611104

Start Date:

May 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905