Trial Outcomes & Findings for Soy Isoflavones and Breast Cancer Risk Reduction (NCT NCT00204490)
NCT ID: NCT00204490
Last Updated: 2024-05-16
Results Overview
Effects of 1 and 2 years of treatment with isoflavones on percent of changes in FGBT%.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
197 participants
Primary outcome timeframe
baseline, and after year 1 and 2 of supplementation
Results posted on
2024-05-16
Participant Flow
Participant milestones
| Measure |
Soy Isoflavones
Each tablet contains 246 mg Novasoy, 676 mg calcium, 15 mg riboflavin, and other inert 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 up to 2 years.
|
Placebo
Carbohydrate: 246 mg maltodextrin, 676 mg calcium, 15 mg riboflavin and other inert 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 up to 2 years.
|
|---|---|---|
|
Enrollment/Allocation of Qualified Women
STARTED
|
99
|
98
|
|
Enrollment/Allocation of Qualified Women
COMPLETED
|
99
|
98
|
|
Enrollment/Allocation of Qualified Women
NOT COMPLETED
|
0
|
0
|
|
Follow-up <1 Year
STARTED
|
99
|
98
|
|
Follow-up <1 Year
COMPLETED
|
83
|
83
|
|
Follow-up <1 Year
NOT COMPLETED
|
16
|
15
|
|
Follow-up >1 to <2 Years
STARTED
|
83
|
83
|
|
Follow-up >1 to <2 Years
COMPLETED
|
68
|
67
|
|
Follow-up >1 to <2 Years
NOT COMPLETED
|
15
|
16
|
|
Follow-up 2 Years
STARTED
|
68
|
67
|
|
Follow-up 2 Years
COMPLETED
|
50
|
47
|
|
Follow-up 2 Years
NOT COMPLETED
|
18
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One placebo and 4 isoflavone participants had missing or unsatisfactory baseline images.
Baseline characteristics by cohort
| Measure |
Soy Isoflavones
n=99 Participants
Each tablet contains 246 mg Novasoy, 676 mg calcium, 15 mg riboflavin, and other inert 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 up to 2 years.
|
Placebo
n=98 Participants
Carbohydrate: 246 mg maltodextrin, 676 mg calcium, 15 mg riboflavin and other inert 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 up to 2 years.
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=98 Participants
|
0 Participants
n=197 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
99 Participants
n=99 Participants
|
98 Participants
n=98 Participants
|
197 Participants
n=197 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=98 Participants
|
0 Participants
n=197 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=99 Participants
|
98 Participants
n=98 Participants
|
197 Participants
n=197 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=98 Participants
|
0 Participants
n=197 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
51 Participants
n=99 Participants
|
39 Participants
n=98 Participants
|
90 Participants
n=197 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=99 Participants
|
59 Participants
n=98 Participants
|
107 Participants
n=197 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=98 Participants
|
0 Participants
n=197 Participants
|
|
Region of Enrollment
United States
|
99 participants
n=99 Participants
|
98 participants
n=98 Participants
|
197 participants
n=197 Participants
|
|
FGBT%
|
24.76 percentage of total breast
STANDARD_DEVIATION 14.54 • n=95 Participants • One placebo and 4 isoflavone participants had missing or unsatisfactory baseline images.
|
23.86 percentage of total breast
STANDARD_DEVIATION 13.99 • n=97 Participants • One placebo and 4 isoflavone participants had missing or unsatisfactory baseline images.
|
24.3 percentage of total breast
STANDARD_DEVIATION 14.23 • n=192 Participants • One placebo and 4 isoflavone participants had missing or unsatisfactory baseline images.
|
PRIMARY outcome
Timeframe: baseline, and after year 1 and 2 of supplementationPopulation: Subjects with at least 1 treatment image.
Effects of 1 and 2 years of treatment with isoflavones on percent of changes in FGBT%.
Outcome measures
| Measure |
Soy Isoflavones
n=68 Participants
Each tablet contains 246 mg Novasoy, 676 mg calcium, 15 mg riboflavin, and other inert 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 up to 2 years.
|
Placebo
n=67 Participants
Carbohydrate: 246 mg maltodextrin, 676 mg calcium, 15 mg riboflavin and other inert 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 up to 2 years.
|
|---|---|---|
|
Fibroglandular Tissue in Total Breast (FGBT%)
Baseline
|
24.94 percentage of total breast tissue
Standard Deviation 14.11
|
25.34 percentage of total breast tissue
Standard Deviation 14.93
|
|
Fibroglandular Tissue in Total Breast (FGBT%)
Year 1
|
24.03 percentage of total breast tissue
Standard Deviation 15.34
|
25.82 percentage of total breast tissue
Standard Deviation 14.72
|
|
Fibroglandular Tissue in Total Breast (FGBT%)
Year 2
|
23.14 percentage of total breast tissue
Standard Deviation 14.58
|
25.36 percentage of total breast tissue
Standard Deviation 13.38
|
PRIMARY outcome
Timeframe: baseline, and after year 1 and 2 of supplementationPopulation: Three Soy Isoflavones participants had missing mammograms.
Area of FGBT in mammogram. The timepoints were combined and summed.
Outcome measures
| Measure |
Soy Isoflavones
n=96 Participants
Each tablet contains 246 mg Novasoy, 676 mg calcium, 15 mg riboflavin, and other inert 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 up to 2 years.
|
Placebo
n=98 Participants
Carbohydrate: 246 mg maltodextrin, 676 mg calcium, 15 mg riboflavin and other inert 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 up to 2 years.
|
|---|---|---|
|
Breast Density by Mammography
|
27.7 percentage of total breast
Standard Deviation 11.62
|
26.73 percentage of total breast
Standard Deviation 10.83
|
SECONDARY outcome
Timeframe: one and two years after dietary supplementPopulation: Intention to treat participants. Two placebo and one isoflavone subjects had breast images but no DXA tests.
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.
Outcome measures
| Measure |
Soy Isoflavones
n=98 Participants
Each tablet contains 246 mg Novasoy, 676 mg calcium, 15 mg riboflavin, and other inert 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 up to 2 years.
|
Placebo
n=96 Participants
Carbohydrate: 246 mg maltodextrin, 676 mg calcium, 15 mg riboflavin and other inert 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 up to 2 years.
|
|---|---|---|
|
Bone Mineral Density
Hip bone mineral density
|
1.01 g/cm^2
Standard Deviation 0.12
|
1.00 g/cm^2
Standard Deviation 0.13
|
|
Bone Mineral Density
Spine bone mineral density
|
1.06 g/cm^2
Standard Deviation 0.11
|
1.06 g/cm^2
Standard Deviation 0.11
|
|
Bone Mineral Density
Whole body bone mineral density
|
1.08 g/cm^2
Standard Deviation 0.09
|
1.07 g/cm^2
Standard Deviation 0.09
|
Adverse Events
Soy Isoflavones
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Soy Isoflavones
n=99 participants at risk
Each tablet contains 246 mg Novasoy, 676 mg calcium, 15 mg riboflavin, and other inert 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 up to 2 years.
|
Placebo
n=98 participants at risk
Carbohydrate: 246 mg maltodextrin, 676 mg calcium, 15 mg riboflavin and other inert 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 up to 2 years.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
1.0%
1/99 • 2 years
|
6.1%
6/98 • 2 years
|
|
Nervous system disorders
Presynocopy
|
0.00%
0/99 • 2 years
|
1.0%
1/98 • 2 years
|
|
Skin and subcutaneous tissue disorders
Hives
|
0.00%
0/99 • 2 years
|
1.0%
1/98 • 2 years
|
|
Skin and subcutaneous tissue disorders
Ear Blister
|
0.00%
0/99 • 2 years
|
1.0%
1/98 • 2 years
|
|
Gastrointestinal disorders
Lower Abdominal Pain
|
0.00%
0/99 • 2 years
|
1.0%
1/98 • 2 years
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/99 • 2 years
|
1.0%
1/98 • 2 years
|
|
Reproductive system and breast disorders
uterus, cervix, cyst and polyp in cervix
|
1.0%
1/99 • 2 years
|
0.00%
0/98 • 2 years
|
|
Infections and infestations
Appendicitis
|
1.0%
1/99 • 2 years
|
0.00%
0/98 • 2 years
|
Additional Information
Dr. Lee Jane W. Lu
University of Texas Medical Branch Galveston
Phone: 409-772-1730
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place