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IH636 Grape Seed Extract in Preventing Breast Cancer in Postmenopausal Women at Risk of Developing Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00100893
Recruitment Status : Completed
First Posted : January 7, 2005
Last Update Posted : June 8, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Breast Cancer Dietary Supplement: IH636 grape seed proanthocyanidin extract Phase 1

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2005
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Dietary Supplement: grape seed proanthocyanidin extract
Administered orally.
Dietary Supplement: IH636 grape seed proanthocyanidin extract
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Androgenic effects as measured by serum testosterone, androstenedione, dehydroepiandrosterone (DHEA), and dehydroepiandrosterone sulfate (DHEAS) [ Time Frame: at 1, 2, 4, 8, and 12 weeks ]
  2. Lipid effects as measured by total cholesterol, LDL, HDL, and triglycerides [ Time Frame: at 12 weeks ]
  3. Bone metabolic effects as measured by bone-specific alkaline phosphatase and N-telopeptides [ Time Frame: at 12 weeks ]
  4. 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 ]
  5. Pharmacokinetics as measured by procyanidins [ Time Frame: before and after first dose and then at 1, 2, 4, 8, and 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes


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



  • 40 to 75


  • 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


  • 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


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


  • Creatinine ≤ 1.5 times ULN


  • No major illness of the cardiovascular system


  • No major illness of the respiratory system


  • 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)


Biologic therapy

  • Not specified


  • 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


  • Not specified


  • Not specified


  • No red wine, red grapes, or white button mushrooms directly before or during study treatment

    • White and seedless grapes allowed
  • No other concurrent therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00100893

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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)
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Responsible Party: City of Hope Medical Center Identifier: NCT00100893    
Other Study ID Numbers: 03178
P30CA033572 ( U.S. NIH Grant/Contract )
CDR0000407637 ( Registry Identifier: NCI PDQ )
First Posted: January 7, 2005    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015
Keywords provided by City of Hope Medical Center:
breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents