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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00100893
First received: January 6, 2005
Last updated: October 4, 2013
Last verified: October 2013
  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 1

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:


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 ]

Enrollment: 37
Study Start Date: January 2005
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
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, see Learn About Clinical Studies.

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
  More Information

Additional Information:
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 4, 2013
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 July 20, 2014