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

Sponsor:	Beckman Research Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
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:	Prevention, Placebo Control
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: Ataxia Telangiectasia Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Estrogen suppression as measured by serum estradiol, estrone, estrone sulfate, and sex hormone binding globulin 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) at 1, 2, 4, 8, and 12 weeks [ Designated as safety issue: No ]
Lipid effects as measured by total cholesterol, LDL, HDL, and triglycerides at 12 weeks [ Designated as safety issue: No ]
Bone metabolic effects as measured by bone-specific alkaline phosphatase and N-telopeptides 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) at 12 weeks [ Designated as safety issue: No ]
Pharmacokinetics as measured by procyanidins 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:	May 2008 (Final data collection date for primary outcome measure)

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	Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org

Sponsors and Collaborators

Beckman Research Institute

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

Study ID Numbers:	CDR0000407637, CHNMC-IRB-03178
Study First Received:	January 6, 2005
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00100893 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

breast cancer

Additional relevant MeSH terms:

Anti-Infective Agents
Antiprotozoal Agents
Antioxidants
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Breast Neoplasms
Protective Agents

Pharmacologic Actions
Antiparasitic Agents
Neoplasms
Proanthocyanidin
Neoplasms by Site
Procyanidin
Therapeutic Uses
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010