Breast CancerPhase 2NCT00204477

Soy Protein and Breast Cancer Risk Reduction

A Phase 2 study testing soy milk and cow's milk in people with Breast Cancer, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Soy consumption has been associated with reduced risk for developing breast cancer. Ovarian hormones and breast density are considered breast cancer risk markers. We propose to test the hypothesis that consumption of soy protein reduces ovarian steroid hormones and results in a corresponding reduction in breast… Read more about this study

Who is it for?: Ages 30 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Breast Cancer
What is being tested?: soy milk and cow's milk
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 321 participants
Where: 1 siteUnited States
Study dates: Apr 2002to 29 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 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

healthy premenopausal women
30 to 40 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, and lifting
on oral contraceptive medications or exogenous hormones
medically prescribed diets
allergic reaction to soy or cow's milk

Trial locations and contacts

1 site in 1 country.

United States1 site

General Clinical Research Center, The University of Texas Medical Branch
Galveston, Texas, 77555-0264

Other trials in United States

About this study

Official title: Soybean Diet and Breast Density

Read the detailed description

The aims will be tested by conducting 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 two different dietary supplements daily for 2 years. The two test diets soy protein drink and caseinate protein drink. Multiple blood, urine, and breast fluid samples will be obtained before and during the dietary intervention period and analyzed for ovarian hormones. At baseline and after the intervention period, breast density, and bone density will be assessed by radiological techniques at baseline and 1 yr and 2 yr after protein drink supplementation. The efficacy of the dietary intervention will be determined by comparing mean changes of ovarian steroids, and density of the breast and bone tissues over the 2 year dietary intervention period in the two diet groups with adjustment for baseline values and individual patient characteristics of interest. We predict that 2 years of soya dietary supplements will reduce breast density, which will be explained by individual hormonal changes.

Conditions: Breast Cancer
Being tested: soy milk, cow's milk
Keywords: soy diet, breast cancer, ovarian hormones, breast density, prevention
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

soy milkDietary supplement
Also called Not applicable, research product
Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.
cow's milkDietary supplement
Also called Not applicable, research product
Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.

Study groups in NCT00204477
Study group	Role	What they receive
Soy milk	Active comparator	Subjects will consume two soy milk drinks from the content of 2 sachets (40 g isoflavone-free soy protein and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g soy protein and 300 mg calcium. Content of sachets will be mixed with ~1.6 liter of water for ingestion. Receives: Dietary Supplement: soy milk
Cow's milk	Placebo comparator	Subjects will consume two cow's milk drinks from the content of 2 sachets (40 g cow's milk protein, casein, and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g cow's milk protein and 300 mg calcium. Content of sachets will be mixed with ~1.6 liter of water for ingestion. Casein is free of ovarian hormones. Receives: Dietary Supplement: cow's milk

What is being measured

The primary outcome is the main question the study is designed to answer.

Mammographic Density (Baseline)
Breast images were acquired by digital mammography. Fibroglandular tissue were segmented from fatty breast tissue. The total breast area is the sum of the fibroglandular tissue area and fatty breast tissue area. Mammographic density (breast density) is the percentage of fibroglandular tissue in the total breast.
Measured: Baseline
Mammographic Density (1 Year)
Breast images were acquired by digital mammography. Fibroglandular tissue were segmented from fatty breast tissue. The total breast area is the sum of the fibroglandular tissue area and fatty breast tissue area. Mammographic density (breast density) is the percentage of fibroglandular tissue in the total breast.
Measured: 1 Year
Mammographic Density (2 Years)
Breast images were acquired by digital mammography. Fibroglandular tissue were segmented from fatty breast tissue. The total breast area is the sum of the fibroglandular tissue area and fatty breast tissue area. Mammographic density (breast density) is the percentage of fibroglandular tissue in the total breast.
Measured: 2 years
Breast Tissue Composition Measured by MRI
Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.
Measured: Baseline
Breast Tissue Composition Measured by MRI
Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.
Measured: 1 Year
Breast Tissue Composition Measured by MRI
Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.
Measured: 2 years
Percentage of Grandular Tissue in Total Breast Measured by MRI
Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.
Measured: Baseline
Percentage of Grandular Tissue in Total Breast Measured by MRI
Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.
Measured: 1 Year
Percentage of Grandular Tissue in Total Breast Measured by MRI
Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 200229 May 2023

First posted20 Sep 2005 (estimated)
Study startApr 2002
Primary completion22 Jul 2011
Study completion29 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 (2)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: Randomized, double-blind, placebo controlled, 2 parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 321 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00204477
Sponsor's protocol ID: 02-422
Other IDs: Army's HSRRB log no. A-10926, UTMB GCRC 533, DAMD17-01-1-0417, M01RR000073, 1UL1RR029876-01
Status last verified: Dec 2023
First submitted: 9 Sep 2005
Last updated: 23 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Will not share as this required financial resources.

Publications

Lu 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
Nayeem F, Anderson KE, Nagamani M, Grady JJ, Lu LJ. Alkaline phosphatase and percentage body fat predict circulating C-reactive protein in premenopausal women. Biomarkers. 2010 Dec;15(8):663-70. doi: 10.3109/1354750X.2010.509811. Epub 2010 Sep 29.
PubMed 20874659

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Soybean Diet and Breast Density
ClinicalTrials.gov ID: NCT00204477
Acronym / sponsor ID: 02-422
Conditions: Breast Cancer
Keywords: soy diet, breast cancer, ovarian hormones, breast density, prevention
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 321 participants (actual)
Lead sponsor: The University of Texas Medical Branch, GalvestonUniversity, hospital or other
Collaborators: U.S. Army Medical Research and Development Command, National Center for Research Resources (NCRR)
Study start: Apr 2002 (actual)
Primary completion: 22 Jul 2011 (actual)
Study completion: 29 May 2023 (actual)
First posted: 20 Sep 2005 (estimated)
Results: Posted 23 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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: Randomized, double-blind, placebo controlled, 2 parallel groups

Arm	Type	Receives
Soy milk	Active comparator	Dietary Supplement: soy milkSubjects will consume two soy milk drinks from the content of 2 sachets (40 g isoflavone-free soy protein and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g soy protein and 300 mg calcium. Content of sachets will be mixed with ~1.6 liter of water for ingestion.
Cow's milk	Placebo comparator	Dietary Supplement: cow's milkSubjects will consume two cow's milk drinks from the content of 2 sachets (40 g cow's milk protein, casein, and 600 mg calcium) in place of a small meal, five days per week. Each sachet will contain 20 g cow's milk protein and 300 mg calcium. Content of sachets will be mixed with ~1.6 liter of water for ingestion. Casein is free of ovarian hormones.

Who may qualify

Ages: 30 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

healthy premenopausal women
30 to 40 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, and 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
soy milkAlso: Not applicable, research productEach drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.	Dietary supplement	Soy milk
cow's milkAlso: Not applicable, research productEach drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.	Dietary supplement	Cow's milk

Primary outcome

Mammographic Density (Baseline)
Time frame: Baseline
Breast images were acquired by digital mammography. Fibroglandular tissue were segmented from fatty breast tissue. The total breast area is the sum of the fibroglandular tissue area and fatty breast tissue area. Mammographic density (breast density) is the percentage of fibroglandular tissue in the total breast.
Mammographic Density (1 Year)
Time frame: 1 Year
Breast images were acquired by digital mammography. Fibroglandular tissue were segmented from fatty breast tissue. The total breast area is the sum of the fibroglandular tissue area and fatty breast tissue area. Mammographic density (breast density) is the percentage of fibroglandular tissue in the total breast.
Mammographic Density (2 Years)
Time frame: 2 years
Breast images were acquired by digital mammography. Fibroglandular tissue were segmented from fatty breast tissue. The total breast area is the sum of the fibroglandular tissue area and fatty breast tissue area. Mammographic density (breast density) is the percentage of fibroglandular tissue in the total breast.
Breast Tissue Composition Measured by MRI
Time frame: Baseline
Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.
Breast Tissue Composition Measured by MRI
Time frame: 1 Year
Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.
Breast Tissue Composition Measured by MRI
Time frame: 2 years
Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.
Percentage of Grandular Tissue in Total Breast Measured by MRI
Time frame: Baseline
Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.
Percentage of Grandular Tissue in Total Breast Measured by MRI
Time frame: 1 Year
Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.
Percentage of Grandular Tissue in Total Breast Measured by MRI
Time frame: 2 years
Breast images acquired by breast magnetic resonance imaging (MRI). The amount of fatty breast tissue,(cc), glandular breast tissue(cc ), total breast (cc), and percentage of glandular tissue in total breast (%) were estimated.

Results and safety

Results posted to the registry on 23 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Soy Milk	161	161
Cow's Milk	160	160

Primary outcome: Mammographic Density (Baseline)

Time frame: Baseline. Mean (Standard Deviation). Unit: percentage of glandular tissue in breast

Measure	Soy Milk n = 157	Cow's Milk n = 157
Value	29.21 (11.44)	28.24 (11.77)

Population analysed: 4 participants images in the cow's milk and 3 images in soy milk were either missing or corrupt.

Primary outcome: Mammographic Density (1 Year)

Time frame: 1 Year. Mean (Standard Deviation). Unit: percentage of glandular tissue in breast

Measure	Soy Milk n = 86	Cow's Milk n = 87
Value	29.37 (12.78)	28.01 (11.56)

Population analysed: Participants completed one year of diet.

Primary outcome: Mammographic Density (2 Years)

Time frame: 2 years. Mean (Standard Deviation). Unit: percentage of glandular tissue in breast

Measure	Soy Milk n = 39	Cow's Milk n = 48
Value	30.75 (13.26)	29.06 (11.80)

Population analysed: Participants completed 2 years of study. 1 image missing from the cow's milk group due to it was corrupt.

Primary outcome: Breast Tissue Composition Measured by MRI

Time frame: Baseline. Mean (Standard Deviation). Unit: cc

Measure	Soy Milk n = 147	Cow's Milk n = 156
Fatty Breast Tissue, cc	589.9 (333.5)	628.1 (373.4)
Glandular Breast Tissue, cc	153.4 (84.48)	156.7 (88.75)
Total Breast, cc	743.3 (350.9)	784.9 (400.8)

Population analysed: 4 participants images in the cow's milk and 14 images in soy milk were either missing or corrupt.

Adverse events

Time frame: 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Soy Milk	0 of 161 (0%)	28 of 161 (17.4%)	0 of 161
Cow's Milk	0 of 160 (0%)	21 of 160 (13.1%)	0 of 160

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Derived from this study: PubMed 20874659Nayeem F, Anderson KE, Nagamani M, Grady JJ, Lu LJ. Alkaline phosphatase and percentage body fat predict circulating C-reactive protein in premenopausal women. Biomarkers. 2010 Dec;15(8):663-70. doi: 10.3109/1354750X.2010.509811. Epub 2010 Sep 29.
Individual participant dataSharing planned: No. Will not share as this required financial resources.

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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 Texas Medical Branch, Galveston, TX 77555

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 soy milk and cow's milk 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 23 Jan 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 23 Jan 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?

Mammographic Density (Baseline) (time frame: Baseline). The study lists 9 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 NCT00204477, which also lists 2 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 23 Jan 2024.