IH636 Grape Seed Extract in Preventing Breast Cancer in Postmenopausal Women at Risk of Developing Breast Cancer - Full Text View

Sponsor:	City of Hope Medical Center
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	City of Hope Medical Center
ClinicalTrials.gov Identifier:	NCT00100893

Purpose

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of IH636 grape seed extract may prevent breast cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of IH636 grape seed extract in preventing breast cancer in postmenopausal women at risk of developing breast cancer.

Condition	Intervention	Phase
Breast Cancer	Dietary Supplement: IH636 grape seed proanthocyanidin extract	Phase I

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Phase I Prevention Trial of ACTIVIN Grape Seed Extract as an Aromatase Inhibitor In Healthy Postmenopausal Women at Risk for Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Diabetes Medicines

U.S. FDA Resources

Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:

Estrogen suppression as measured by serum estradiol, estrone, estrone sulfate, and sex hormone binding globulin [ Time Frame: at 1, 2, 4, 8, and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Androgenic effects as measured by serum testosterone, androstenedione, dehydroepiandrosterone (DHEA), and dehydroepiandrosterone sulfate (DHEAS) [ Time Frame: at 1, 2, 4, 8, and 12 weeks ] [ Designated as safety issue: No ]
Lipid effects as measured by total cholesterol, LDL, HDL, and triglycerides [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
Bone metabolic effects as measured by bone-specific alkaline phosphatase and N-telopeptides [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
Insulin regulatory effects as measured by insulin-like growth factor 1 (IGF1) and insulin-like growth factor-binding protein 3 (IGFBP3) [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
Pharmacokinetics as measured by procyanidins [ Time Frame: before and after first dose and then at 1, 2, 4, 8, and 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	January 2005
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Dose escalation as follows: 50 mg/day, 300 mg/day, 1000 mg/day, 2000 mg/day, 2800 mg/day, 4000 mg/day, 4800 mg/day and 6000 mg/day in separate patient groups for each dosage

Detailed Description:

OBJECTIVES:

Determine the efficacy of IH636 grape seed proanthocyanidin extract, in terms of suppression of estrogen biosynthesis, in healthy post-menopausal women at high risk of developing breast cancer.
Determine the safety and tolerability of this dietary supplement, in terms of symptoms and changes in markers of bone and lipid metabolism and in markers of nonspecific adrenal suppression, in these participants.
Determine, preliminarily, an optimum biologic dose of this dietary supplement, as defined by suppression of serum estradiol, in these participants.
Determine a minimum duration of use of this dietary supplement to achieve aromatase inhibition in these participants.

OUTLINE: This is a pilot, dose-finding, placebo-controlled study.

Participants receive oral placebo once or twice daily on days -14 to 0. Participants then receive oral IH636 grape seed proanthocyanidin extract once or twice daily on days 1-85. Treatment continues in the absence of toxicity.

Cohorts of 6 participants receive one of four dose levels of IH636 grape seed proanthocyanidin extract up to an established safe dose.

PROJECTED ACCRUAL: A total of 24 participants will be accrued for this study within 12 months.

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

At risk of developing breast cancer
No history of breast cancer or ductal carcinoma in situ

PATIENT CHARACTERISTICS:

Age

40 to 75

Sex

Female

Menopausal status

Postmenopausal, defined by 1 of the following criteria:
- No spontaneous menses for ≥ 12 months
- Prior bilateral oophorectomy
- Prior hysterectomy with follicle-stimulating hormone within menopausal range

Performance status

ECOG 0-1

Life expectancy

Not specified

Hematopoietic

Hemoglobin ≥ 9.0 g/dL
Platelet count ≥ 100,000/mm^3
WBC ≥ 3,500/mm^3
Absolute granulocyte count ≥ 1,500/mm^3
No coagulation disorders

Hepatic

SGOT and SGPT ≤ 2 times upper limit of normal (ULN)
Bilirubin ≤ 1.5 times ULN

Renal

Creatinine ≤ 1.5 times ULN

Cardiovascular

No major illness of the cardiovascular system

Pulmonary

No major illness of the respiratory system

Other

No history of other invasive cancer within the past 5 years except squamous cell or basal cell skin cancer
No major systemic infection
No Cushing's syndrome or adrenal insufficiency
No osteoporosis, defined as a bone mineral density T-score ≥ -2.5 on dual-energy x-ray absorptiometry scan (calcium and/or cholecalciferol [vitamin D] supplementation AND/OR bisphosphonate therapy allowed provided participant is on a stable dose during study participation)

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

More than 3 months since prior hormone-modifying medications, including any of the following:
- Oral contraceptives
- Hormone replacement therapy
- Selective estrogen receptor modifiers
- Aromatase inhibitors
- Gonadotropin-releasing hormone modifiers
Concurrent dehydroepiandrosterone (DHEA) allowed, provided dose remains constant during study participation

Radiotherapy

Not specified

Surgery

Not specified

Other

No red wine, red grapes, or white button mushrooms directly before or during study treatment
- White and seedless grapes allowed
No other concurrent therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100893

Locations

United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000

Sponsors and Collaborators

City of Hope Medical Center

National Cancer Institute (NCI)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	City of Hope Medical Center
ClinicalTrials.gov Identifier:	NCT00100893 History of Changes
Other Study ID Numbers:	03178, P30CA033572, CHNMC-IRB-03178, CDR0000407637
Study First Received:	January 6, 2005
Last Updated:	October 13, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:

breast cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Proanthocyanidin
Procyanidin
Grape Seed Extract
Aromatase Inhibitors
Antioxidants
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 12, 2012