Resveratrol in Postmenopausal Women With High Body Mass Index

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

This pilot phase I trial studies resveratrol in postmenopausal women with high body mass index. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of resveratrol may keep cancer from forming. Studying samples of blood and urine in the laboratory from postmenopausal women who are taking resveratrol may help doctors learn more about the effects of resveratrol on biomarkers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Resveratrol

Criteria

Inclusion Criteria:

• Healthy postmenopausal women with a body mass index (BMI) of 25 kg/m^2 or greater

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; Karnofsky 70% or above

• Leukocytes >= 3,000/uL

• Absolute neutrophil count (ANC) >= 1,500/uL

• Platelets >= 100,000/uL

• Total bilirubin =< 2.0 mg/dL

• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 1.5 times upper limit of normal (ULN)

• Creatinine =< 1.0 times ULN

• Ability and willingness to limit resveratrol-containing foods to no more than one serving each per day for about 14 weeks

• Negative mammogram or negative workup of mammographic findings within prior 12 months prior to enrollment for women >= 50 years of age

• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Have had invasive cancer(s) within the past 5 years except non-melanoma skin cancer

• Within 3 months of or concurrent usage of any other investigational agents

• History of allergic reactions attributed to resveratrol

• Unwilling or unable to refrain from taking herbal medicines and dietary supplements

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

• Within 3 months of or concurrent estrogen or progesterone replacement therapy, oral contraceptives, androgens, luteinizing hormone-releasing hormone analogs, prolactin inhibitors, or antiandrogens; vaginal estrogen is acceptable.

Within 3 months of or concurrent usage of tamoxifen, raloxifene, other selective estrogen-receptor modulators, or aromatase inhibitors

• Regular usage (more than 2 times a week) of estrogenic supplements or herbal remedies (e.g., Remifemin, black cohosh, red clover, dong quai, soy isoflavones, dehydroepiandrosterone [DHEA], flaxseed, diindolylmethane [DIM], genistein, and daidzein) within the past 3 months or concurrently; dietary consumption of phytoestrogens/isoflavones (such as soy, tofu, millet, barley, natto, tempeh, miso, soy milk, soy sauce) is acceptable as these sources are not concentrated

• Concurrent use of anti-diabetic drugs such as:

• Insulin

• Sulfonylureas (e.g., glipizide, glyburide, or glimepiride)

• Meglitinides (e.g., repaglinide or nateglinide)

• Biguanides (e.g., metformin)

• Thiazolidinediones (e.g., rosiglitazone or pioglitazone)

• Alpha-glucosidase inhibitors (e.g., acarbose or miglitol)

• Dipeptidyl peptidase-4 (DPP-4) inhibitors (e.g., sitagliptin)

• Concurrent use of warfarin or phenytoin