Breast CancerPhase 2NCT00204490
Soy Isoflavones and Breast Cancer Risk Reduction
A Phase 2 study testing isoflavones and carbohydrate in people with Breast Cancer, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
Soy consumption has been associated with reduced risk for developing breast cancer. Soy contains isoflavones which are weak estrogens. The roles of soy isoflavones in reducing breast cancer risk are currently unclear. Breast density has been considered as a breast cancer risk marker. Read more about this study
- Who is it for?
- Ages 30 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- isoflavones and carbohydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 197 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to 31 May 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy premenopausal women
- 30 to 42 years old
- normal mammograms
- regular menstrual cycles
Who cannot join
- abnormal mammograms
- first degree relatives with breast cancer
- pregnant or lactating
- peri- or post-menopause
- breast augmentation, reduction or lifting
- on oral contraceptive medications or exogenous hormones
- medically prescribed diets
- allergic reaction to soy products
Trial locations and contacts
1 site in 1 country.
United States1 site
General Clinical Reserach Center, The University of Texas Medical Branch
Galveston, Texas, 77555-0264
About this study
Official title: Mammographic Density and Soy Isoflavones
Soy consumption has been associated with reduced risk for developing breast cancer. Soy contains isoflavones which are weak estrogens. The roles of soy isoflavones in reducing breast cancer risk are currently unclear. Breast density has been considered as a breast cancer risk marker. We hypothesize that because isoflavones have estrogen-like activities, breast density and possibly bone density will be lower in women on soy-isoflavones.
Read the detailed description
This is a randomized, double-blind study, with two arms and 100 women in each arm. Premenopausal women will be recruited and randomly allocated to take one of the two different dietary supplements in pills daily for 2 years. The two supplements are soy isoflavones (treatment) and placebo (carbohydrates). Both treatment and placebo pills will contain multi-vitamins and minerals. Multiple blood, urine, and breast fluid samples will be obtained before and during the dietary supplement periods and analyzed for biomarkers of breast cancer risk. At baseline and after the intervention period, breast density and bone density will be assessed by radiologic techniques. The efficacy of the dietary intervention will be determined by comparing mean changes of serum markers for breast cancer risk,dense breast tissue, and bone mineral density over the two year dietary intervention period in the two supplement groups with adjustment for baseline values and individual patient characteristics of interest. We predict that 2 years of soy isoflavone supplement will reduce breast density, which may be explained by individual changes in serum markers of breast cancer risk.
- Conditions
- Breast Cancer
- Being tested
- isoflavones, carbohydrate
- Keywords
- soy, isoflavones, phytoestrogens, prevention, mammographic density, bone density
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isoflavonesDietary supplement
Also called Isoflavone pill
soy isoflavones: Each tablet contains 246 mg Novasoy, 676 mg calcium, 15 mg riboflavin, and other innert materials to a total weight of 1000 mg. Subject takes two isoflavone tablets plus 1 multi-vitamin per day for five days per week for upto 2 years.
carbohydrateDietary supplement
Also called Sugar pill
carbohydrate: 246 mg maltodextrin, 676 mg calcium, 15 mg riboflavin and other innert ingredients to a total weight of 1000 mg per tablet. subject takes two tablets plus one multivitamin per day for five days per week for upto 2 years.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | soy isoflavones Receives: Dietary Supplement: isoflavones |
| 2 | Placebo comparator | carbohydrates (maltodextrin) Receives: Dietary Supplement: carbohydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibroglandular Tissue in Total Breast (FGBT%)
Effects of 1 and 2 years of treatment with isoflavones on percent of changes in FGBT%.
Measured: baseline, and after year 1 and 2 of supplementation
Breast Density by Mammography
Area of FGBT in mammogram. The timepoints were combined and summed.
Measured: baseline, and after year 1 and 2 of supplementation
Secondary outcomes (1)
Bone Mineral Density
Bone mineral density of hip, spine and whole body bone mineral density as measured by dual x-ray absorptiometry. The timepoints were combined and summed.
Measured: one and two years after dietary supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2004
- Primary completion10 Dec 2012
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)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 The University of Texas Medical Branch, GalvestonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group received soy isoflavones (60 mg daidzein, 60 mg gensitein and 16.6 mg glycitein, all as aglycone equivalent) Another group, carbohydrate filler
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Center for Research Resources (NCRR)
- Responsible party
- Sponsor
- Investigators
- Lee-Jane W Lu, Ph.D., Principal investigator, The University of Teas Medical Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204490
- Sponsor's protocol ID
- 03-260
- Other IDs
- UTMB GCRC #635, R01CA095545, M01RR000073, 1UL1RR029876-01
- Status last verified
- May 2024
- First submitted
- 12 Sep 2005
- Last updated
- 16 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lu LW, Chen NW, Brunder DG, Nayeem F, Nagamani M, Nishino TK, Anderson KE, Khamapirad T. Soy isoflavones decrease fibroglandular breast tissue measured by magnetic resonance imaging in premenopausal women: A 2-year randomized double-blind placebo controlled clinical trial. Clin Nutr ESPEN. 2022 Dec;52:158-168. doi: 10.1016/j.clnesp.2022.10.007. Epub 2022 Oct 26.
PubMed 36513449Lu LW, Chen NW, Nayeem F, Nagamani M, Anderson KE. Soy isoflavones interact with calcium and contribute to blood pressure homeostasis in women: a randomized, double-blind, placebo controlled trial. Eur J Nutr. 2020 Sep;59(6):2369-2381. doi: 10.1007/s00394-019-02085-3. Epub 2019 Sep 18.
PubMed 31535213Lu LW, Chen NW, Nayeem F, Ramanujam VS, Kuo YF, Brunder DG, Nagamani M, Anderson KE. Novel effects of phytoestrogenic soy isoflavones on serum calcium and chloride in premenopausal women: A 2-year double-blind, randomized, placebo-controlled study. Clin Nutr. 2018 Dec;37(6 Pt A):1862-1870. doi: 10.1016/j.clnu.2017.11.002. Epub 2017 Nov 11.
PubMed 29183775Lu LJ, Nishino TK, Johnson RF, Nayeem F, Brunder DG, Ju H, Leonard MH, Grady JJ, Khamapirad T. Comparison of breast tissue measurements using magnetic resonance imaging, digital mammography and a mathematical algorithm. Phys Med Biol. 2012 Nov 7;57(21):6903-27. doi: 10.1088/0031-9155/57/21/6903. Epub 2012 Oct 9.
PubMed 23044556
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mammographic Density and Soy Isoflavones
- ClinicalTrials.gov ID
- NCT00204490
- Acronym / sponsor ID
- 03-260
- Conditions
- Breast Cancer
- Keywords
- soy, isoflavones, phytoestrogens, prevention, mammographic density, bone density
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Center for Research Resources (NCRR)
- Study start
- Apr 2004 (actual)
- Primary completion
- 10 Dec 2012 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 16 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Soy consumption has been associated with reduced risk for developing breast cancer. Soy contains isoflavones which are weak estrogens. The roles of soy isoflavones in reducing breast cancer risk are currently unclear. Breast density has been considered as a breast cancer risk marker. We hypothesize that because isoflavones have estrogen-like activities, breast density and possibly bone density will be lower in women on soy-isoflavones.
Detailed description
This is a randomized, double-blind study, with two arms and 100 women in each arm. Premenopausal women will be recruited and randomly allocated to take one of the two different dietary supplements in pills daily for 2 years. The two supplements are soy isoflavones (treatment) and placebo (carbohydrates). Both treatment and placebo pills will contain multi-vitamins and minerals. Multiple blood, urine, and breast fluid samples will be obtained before and during the dietary supplement periods and analyzed for biomarkers of breast cancer risk. At baseline and after the intervention period, breast density and bone density will be assessed by radiologic techniques. The efficacy of the dietary intervention will be determined by comparing mean changes of serum markers for breast cancer risk,dense breast tissue, and bone mineral density over the two year dietary intervention period in the two supplement groups with adjustment for baseline values and individual patient characteristics of interest. We predict that 2 years of soy isoflavone supplement will reduce breast density, which may be explained by individual changes in serum markers of breast cancer risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- One group received soy isoflavones (60 mg daidzein, 60 mg gensitein and 16.6 mg glycitein, all as aglycone equivalent) Another group, carbohydrate filler
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: isoflavonessoy isoflavones |
| 2 | Placebo comparator | Dietary Supplement: carbohydratecarbohydrates (maltodextrin) |
Who may qualify
- Ages
- 30 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy premenopausal women
- 30 to 42 years old
- normal mammograms
- regular menstrual cycles
Key exclusion criteria (8 listed)
- abnormal mammograms
- first degree relatives with breast cancer
- pregnant or lactating
- peri- or post-menopause
- breast augmentation, reduction or lifting
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 |
|---|---|---|
| isoflavonesAlso: Isoflavone pillsoy isoflavones: Each tablet contains 246 mg Novasoy, 676 mg calcium, 15 mg riboflavin, and other innert materials to a total weight of 1000 mg. Subject takes two isoflavone tablets plus 1 multi-vitamin per day for five days per week for upto 2 years. | Dietary supplement | 1 |
| carbohydrateAlso: Sugar pillcarbohydrate: 246 mg maltodextrin, 676 mg calcium, 15 mg riboflavin and other innert ingredients to a total weight of 1000 mg per tablet. subject takes two tablets plus one multivitamin per day for five days per week for upto 2 years. | Dietary supplement | 2 |
Primary outcome
Fibroglandular Tissue in Total Breast (FGBT%)
Time frame: baseline, and after year 1 and 2 of supplementation
Effects of 1 and 2 years of treatment with isoflavones on percent of changes in FGBT%.
Breast Density by Mammography
Time frame: baseline, and after year 1 and 2 of supplementation
Area of FGBT in mammogram. The timepoints were combined and summed.
1 secondary outcome
Bone Mineral Density
Time frame: one and two years after dietary supplement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36513449Lu LW, Chen NW, Brunder DG, Nayeem F, Nagamani M, Nishino TK, Anderson KE, Khamapirad T. Soy isoflavones decrease fibroglandular breast tissue measured by magnetic resonance imaging in premenopausal women: A 2-year randomized double-blind placebo controlled clinical trial. Clin Nutr ESPEN. 2022 Dec;52:158-168. doi: 10.1016/j.clnesp.2022.10.007. Epub 2022 Oct 26.
- Derived from this study: PubMed 31535213Lu LW, Chen NW, Nayeem F, Nagamani M, Anderson KE. Soy isoflavones interact with calcium and contribute to blood pressure homeostasis in women: a randomized, double-blind, placebo controlled trial. Eur J Nutr. 2020 Sep;59(6):2369-2381. doi: 10.1007/s00394-019-02085-3. Epub 2019 Sep 18.
- Derived from this study: PubMed 29183775Lu LW, Chen NW, Nayeem F, Ramanujam VS, Kuo YF, Brunder DG, Nagamani M, Anderson KE. Novel effects of phytoestrogenic soy isoflavones on serum calcium and chloride in premenopausal women: A 2-year double-blind, randomized, placebo-controlled study. Clin Nutr. 2018 Dec;37(6 Pt A):1862-1870. doi: 10.1016/j.clnu.2017.11.002. Epub 2017 Nov 11.
- Derived from this study: PubMed 23044556Lu LJ, Nishino TK, Johnson RF, Nayeem F, Brunder DG, Ju H, Leonard MH, Grady JJ, Khamapirad T. Comparison of breast tissue measurements using magnetic resonance imaging, digital mammography and a mathematical algorithm. Phys Med Biol. 2012 Nov 7;57(21):6903-27. doi: 10.1088/0031-9155/57/21/6903. Epub 2012 Oct 9.
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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.
Lee-Jane W Lu, Ph.D. principal investigator
The University of Teas Medical Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing isoflavones and carbohydrate in people with Breast Cancer, run by The University of Texas Medical Branch, Galveston 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?
The sponsor lists 4 inclusion and 8 exclusion criteria. 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 16 May 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Fibroglandular Tissue in Total Breast (FGBT%) (time frame: baseline, and after year 1 and 2 of supplementation). The study lists 2 primary outcomes in all. 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 NCT00204490, which also lists 4 linked publications.
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 16 May 2024.