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

NCT00100893 | Completed Phase 1 DMC

• 4 other identifiers: 03178P30CA033572CHNMC-IRB-03178CDR0000407637
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

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

  at 1, 2, 4, 8, and 12 weeks

Secondary Outcomes (5)

• Androgenic effects as measured by serum testosterone, androstenedione, dehydroepiandrosterone (DHEA), and dehydroepiandrosterone sulfate (DHEAS)

  at 1, 2, 4, 8, and 12 weeks

• Lipid effects as measured by total cholesterol, LDL, HDL, and triglycerides

  at 12 weeks

• Bone metabolic effects as measured by bone-specific alkaline phosphatase and N-telopeptides

  at 12 weeks

• Insulin regulatory effects as measured by insulin-like growth factor 1 (IGF1) and insulin-like growth factor-binding protein 3 (IGFBP3)

  at 12 weeks

• Pharmacokinetics as measured by procyanidins

  before and after first dose and then at 1, 2, 4, 8, and 12 weeks

Study Arms (1)

Dietary Supplement: grape seed proanthocyanidin extract

EXPERIMENTAL

Administered orally.

Dietary Supplement: IH636 grape seed proanthocyanidin extract

Interventions

IH636 grape seed proanthocyanidin extract DIETARY_SUPPLEMENT

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

Dietary Supplement: grape seed proanthocyanidin extract

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Grape Seed Proanthocyanidins

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2005
• First Posted: January 7, 2005
• Study Start: January 1, 2005
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

US (1)