Resveratrol in Postmenopausal Women With High Body Mass Index

National Cancer Institute (NCI)

Status and phase

Completed

Phase 1

Conditions

Healthy, no Evidence of Disease

Treatments

Drug: resveratrol

Other: laboratory biomarker analysis

Study type

Interventional

Funder types

NIH

Identifiers

NCT01370889

P30CA023074 (U.S. NIH Grant/Contract)

NCI-2011-02593 (Registry Identifier)

10-0653-04 (Other Identifier)

N01CN35158 (U.S. NIH Grant/Contract)

CDR0000701405

UAZ08-12-01 (Other Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

I. To determine the effect of pharmacological doses of resveratrol on serum estradiol levels in post-menopausal women with high body mass index (BMI).

SECONDARY OBJECTIVES:

I. Assess the effect of resveratrol on serum estrone, testosterone, and sex hormone-binding globulin (SHBP).

II. Assess the effect of resveratrol on serum levels of insulin and C-peptide. III. Assess the effect of resveratrol on adipocytokine expression and secretion as measured by serum leptin and adiponectin.

IV. Assess the effect of resveratrol on inflammatory cytokines as measured by serum C-reactive protein (CRP).

V. Assess the effect of resveratrol on oxidative stress as measured by urinary 8-isoprostaglandin F2 alpha (8-iso-PGF2 alpha) and 8-hydroxydeoxyguanosine (8OHdG).

VI. Assess the safety of resveratrol intervention as measured by reported adverse events, complete blood count with differential (CBC/diff), comprehensive metabolic panel (CMP), and lipid profile.

VII. Assess the relationship between systemic study agent exposure and biomarker modulation.

OUTLINE:

Patients receive resveratrol orally (PO) once daily (QD) for 12 weeks.

After completion of study therapy, patients are followed up for 2 weeks

Enrollment

46 patients

Sex

Female

Ages

35+ years old

Volunteers

Accepts Healthy Volunteers

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