Breast CancerPhase 1NCT00099008
Genistein in Preventing Breast or Endometrial Cancer in Healthy Postmenopausal Women
A Phase 1 study testing Genistein in people with Breast Cancer and Endometrial Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Endometrial Cancer
- What is being tested?
- Genistein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Jul 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
About this study
Official title: Phase I Multiple Dose Clinical Study of Soy Isoflavones in Healthy, Post-Menopausal Women
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.
Read the detailed description
OBJECTIVES:
- 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.
- Compare the effects of these drugs on gene expression in an estrogen-sensitive tissue by oligoarray profiling in these participants.
- Determine the effect of genistein on estrogenic effects by self-reported side effects, measurement of sex hormone-binding globulin, follicle-stimulating hormone, luteinizing hormone, and estrogen levels, and expression of known estrogen-sensitive genes in these participants.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Participants are stratified according to their study ID numbers. Participants are randomized to 1 of 2 treatment arms.
- Arm I: Participants receive oral genistein twice daily on days 1-84.
- Arm II: Participants receive oral placebo twice daily on days 1-84. In both arms, treatment continues in the absence of dysplasia, malignancy, unacceptable toxicity, or gross noncompliance.
Participants are followed at days 7, 14, 28, 56, and 84 during study treatment and at day 28 after completion of study treatment.
PROJECTED ACCRUAL: A total of 30 participants (20 for arm I and 10 for arm II) will be accrued for this study.
- Conditions
- Breast Cancer, Endometrial Cancer
- Being tested
- Genistein, Placebo
- Keywords
- breast cancer, endometrial cancer
- Medical subject headings
- Breast Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenisteinDietary supplement
Also called PTI G-2535
oral Genistein twice daily on days 1-84
PlaceboDietary supplement
oral Placebo twice daily on days 1-84
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Genistein Receives: Dietary Supplement: Genistein |
| Arm II | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2004 (estimated)
- Study startMar 2004
- Primary completionJul 2005
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Steven H. Zeisel, MD, PhD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099008
- Sponsor's protocol ID
- UNC-GCRC-2107
- Other IDs
- CDR0000393450
- Status last verified
- May 2013
- First submitted
- 8 Dec 2004
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18446090
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Multiple Dose Clinical Study of Soy Isoflavones in Healthy, Post-Menopausal Women
- ClinicalTrials.gov ID
- NCT00099008
- Acronym / sponsor ID
- UNC-GCRC-2107
- Conditions
- Breast Cancer, Endometrial Cancer
- Keywords
- breast cancer, endometrial cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 9 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- 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.
- Compare the effects of these drugs on gene expression in an estrogen-sensitive tissue by oligoarray profiling in these participants.
- Determine the effect of genistein on estrogenic effects by self-reported side effects, measurement of sex hormone-binding globulin, follicle-stimulating hormone, luteinizing hormone, and estrogen levels, and expression of known estrogen-sensitive genes in these participants.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Participants are stratified according to their study ID numbers. Participants are randomized to 1 of 2 treatment arms.
- Arm I: Participants receive oral genistein twice daily on days 1-84.
- Arm II: Participants receive oral placebo twice daily on days 1-84. In both arms, treatment continues in the absence of dysplasia, malignancy, unacceptable toxicity, or gross noncompliance.
Participants are followed at days 7, 14, 28, 56, and 84 during study treatment and at day 28 after completion of study treatment.
PROJECTED ACCRUAL: A total of 30 participants (20 for arm I and 10 for arm II) will be accrued for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Dietary Supplement: GenisteinGenistein |
| Arm II | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GenisteinAlso: PTI G-2535oral Genistein twice daily on days 1-84 | Dietary supplement | Arm I |
| Placebooral Placebo twice daily on days 1-84 | Dietary supplement | Arm II |
Primary outcome
Efficacy of genistein on DNA and apoptosis
Time frame: 112 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2013.
- Results publication: PubMed 18446090Pop 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven H. Zeisel, MD, PhD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Genistein in people with Breast Cancer and Endometrial Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of genistein on DNA and apoptosis (time frame: 112 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00099008, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2013.