Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments standardized freeze-dried table grape powder, laboratory biomarker analysis, pharmacological study
Sponsor Mayo Clinic
Collaborator National Cancer Institute (NCI)
Start date May 2008
End date December 2016
Trial size 25 participants
Trial identifier NCT00611104, 06-002061, CDR0000581219, MC0536, P30CA015083

Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Studying samples of blood and urine in the laboratory from participants receiving freeze-dried table grape powder may help doctors understand the effect of this drug on blood estrogen levels.

PURPOSE: This clinical trial is studying the effect of freeze-dried table grape powder on blood estrogen levels in postmenopausal women.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective

Primary Outcomes

Measure
Serum levels of plasma estrone (E1), estradiol, E1-conjugates, and E1-sulfates
time frame:
Bioavailability of the freeze-dried table grape powder in humans
time frame:

Eligibility Criteria

Female participants from 18 years up to 120 years old.

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

Additional Information

Official title Evaluation of the Aromatase Inhibition Potential of Standardized Grape Extract
Principal investigator Janet E. Olson, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.