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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IH636 grape seed proanthocyanidin extract
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring breast cancer

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • City of Hope Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dietary Supplement: grape seed proanthocyanidin extract

Arm Description

Administered orally.

Outcomes

Primary Outcome Measures

Estrogen suppression as measured by serum estradiol, estrone, estrone sulfate, and sex hormone binding globulin

Secondary Outcome Measures

Androgenic effects as measured by serum testosterone, androstenedione, dehydroepiandrosterone (DHEA), and dehydroepiandrosterone sulfate (DHEAS)
Lipid effects as measured by total cholesterol, LDL, HDL, and triglycerides
Bone metabolic effects as measured by bone-specific alkaline phosphatase and N-telopeptides
Insulin regulatory effects as measured by insulin-like growth factor 1 (IGF1) and insulin-like growth factor-binding protein 3 (IGFBP3)
Pharmacokinetics as measured by procyanidins

Full Information

First Posted
January 6, 2005
Last Updated
June 3, 2015
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00100893
Brief Title
IH636 Grape Seed Extract in Preventing Breast Cancer in Postmenopausal Women at Risk of Developing Breast Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary Supplement: grape seed proanthocyanidin extract
Arm Type
Experimental
Arm Description
Administered orally.
Intervention Type
Dietary Supplement
Intervention Name(s)
IH636 grape seed proanthocyanidin extract
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
Androgenic effects as measured by serum testosterone, androstenedione, dehydroepiandrosterone (DHEA), and dehydroepiandrosterone sulfate (DHEAS)
Time Frame
at 1, 2, 4, 8, and 12 weeks
Title
Lipid effects as measured by total cholesterol, LDL, HDL, and triglycerides
Time Frame
at 12 weeks
Title
Bone metabolic effects as measured by bone-specific alkaline phosphatase and N-telopeptides
Time Frame
at 12 weeks
Title
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
Title
Pharmacokinetics as measured by procyanidins
Time Frame
before and after first dose and then at 1, 2, 4, 8, and 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States

12. IPD Sharing Statement

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

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