Genistein in Preventing Breast or Endometrial Cancer in Healthy Postmenopausal Women

NCT00099008 | Completed Phase 1 DMC

• 2 other identifiers: UNC-GCRC-2107CDR0000393450
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of genistein may be effective in preventing breast or endometrial cancer. PURPOSE: This randomized phase I trial is studying the effectiveness of genistein in preventing breast or endometrial cancer in healthy postmenopausal women.

Conditions

Breast Cancer; Endometrial Cancer

Keywords

breast cancer; endometrial cancer

Outcome Measures

Primary Outcomes (1)

• Efficacy of genistein on DNA and apoptosis

  Compare the effects of genistein vs placebo on DNA damage and apoptosis by conducting COMET, TUNEL, Caspase-3, and AP site assays in healthy postmenopausal women.

  112 days

Study Arms (2)

Arm I

EXPERIMENTAL

Genistein

Dietary Supplement: Genistein

Arm II

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Genistein DIETARY_SUPPLEMENT

oral Genistein twice daily on days 1-84

Also known as: PTI G-2535

Arm I

Placebo DIETARY_SUPPLEMENT

oral Placebo twice daily on days 1-84

Arm II

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Healthy participants * Papanicolaou test (pap smear) normal within the past 13 months * Mammogram normal within the past 13 months * No history of breast cancer * Not at high-risk (5-year risk \< 1.9%) for breast cancer according to NCI's Breast Cancer Risk Assessment Tool * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 45 to 70 Sex * Female Menopausal status * Postmenopausal * Last spontaneous menstrual bleeding \> 12 months ago Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * WBC ≥ 3,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 2.0 mg/dL * ALT and AST \< 2 times normal * No significant abnormality of the liver by physical exam Renal * Creatinine \< 2.0 mg/dL Cardiovascular * No significant cardiac disease * No New York Heart Association class III or IV heart disease * No significant abnormality of the heart by physical exam Pulmonary * No significant abnormality of the lung by physical exam Other * Body mass index \< 35 * Follicle-stimulating hormone \> 27 mIU/mL * Thyroid or endocrine function test normal * Alcohol intake ≤ 2 drinks/day or ≤14 drinks/week * Not pregnant * No intermediate equol values (≥10 ug/L to ≤ 20 ug/L) on soy challenge * No history of seizures * No significant abnormality of the spleen or other abdominal organs by physical exam * No neurologic abnormality by physical exam * No significant metabolic abnormality on the biochemical screen * No history of substance abuse or addiction * No tobacco use * No diets containing \> 20 mg of genistein/day or \> 40 mg isoflavone/day * No known intolerance to soy * No other serious medical illness * No active malignancy or malignancy initially diagnosed within the past 2 years except curatively treated nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 2 years since prior chemotherapy * No concurrent chemotherapy Endocrine therapy * More than 3 months since prior hormonal or estrogen therapy * More than 3 months since prior tamoxifen or other selective estrogen-receptor modulators * More than 1 month since prior supplements containing phytoestrogens or that have estrogenic side effects (soy isoflavones or PC-SPECS) * No concurrent thyroid medication * Other concurrent endocrine medication allowed provided medication was initiated ≥ 3 months before study entry AND participant has been on a stable regimen for the past 3 months Radiotherapy * Not specified Surgery * No prior hysterectomy or oophorectomy Other * More than 3 months since prior antibiotics

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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Related Publications (1)

• Pop EA, Fischer LM, Coan AD, Gitzinger M, Nakamura J, Zeisel SH. Effects of a high daily dose of soy isoflavones on DNA damage, apoptosis, and estrogenic outcomes in healthy postmenopausal women: a phase I clinical trial. Menopause. 2008 Jul-Aug;15(4 Pt 1):684-92. doi: 10.1097/gme.0b013e318167b8f2.

  PMID: 18446090 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Endometrial Neoplasms

Interventions

Genistein

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Steven H. Zeisel, MD, PhD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2004
• First Posted: December 9, 2004
• Study Start: March 1, 2004
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2006
• Last Updated: May 21, 2013

Record last verified: 2013-05

Locations

US (1)