Breast CancerMiSoNCT03686098
The Malaysian Soy and Mammographic Density Study
A study testing Dietary soy and Soy Supplement in people with Breast Cancer and Mammographic Density, run by Cancer Research Malaysia at 1 site in Malaysia.
Trial summary
Globally, breast cancer is the most common cancer and the main cause of deaths due to cancer. This is attributed to changes in reproductive habits as well as an increasingly sedentary lifestyle, with low physical activity and diets rich in saturated fats but low in fiber. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Mammographic Density
- What is being tested?
- Dietary soy and Soy Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 1 siteMalaysia
- Study dates
- 19 Nov 2018to Jun 2020
- Phase
- Interventional
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Enrolled in the Malaysian Mammography Study and agreed to be contacted
- Aged between 45 and 65 years old at study recruitment (i.e. as of June 2018)
- No genetic predisposition to breast cancer (carriers of the BRCA1 and BRCA2 mutations)
- Measurable amount of mammographic density (at least 4.5% Volpara percent mammographic density).
Who cannot join
- Personal history of breast cancer
- Personal history of other cancers, stroke, and other serious health conditions
- Personal history of benign breast disease
- Pre-menopausal (regular menstrual periods) or early peri-menopausal women (irregular menstrual period with a menstrual period in the past 3 months)
- Women who have a history of high uric acid, gout and associated conditions
- Women who have been diagnosed as diabetic or pre-diabetic
Show all 15Show fewer
- Women who have been diagnosed with hypothyroidism
- Women who have gastrointestinal conditions (i.e. irritable bowel syndrome)
- Women who are allergic or intolerant to soy and soy products
- Currently (within the last 6 months) on hormone replacement therapy drugs, including alternative and traditional therapies for menopause symptom management
- Currently (within the last 6 months) a smoker
- Women who report a high soy diet (consuming soy foods at least once a day or are currently taking soy supplements
- Women who have had a mammogram in the past 12 months
- Women with breast augmentation
- Women with an abnormal or suspicious mammogram at recruitment. This includes women who are scored 2-5 using American College of Radiology's BIRADS (Version 5), unless reported as normal after additional tests (i.e. ultrasound). For women with dense breast, we will exclude women with an abnormal ultrasound (indicative of benign or malignant disease).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Malaysian Soy and Mammographic Density (MiSo) Study: A Randomized, Three-arm, Controlled Clinical Trial to Investigate the Impact of Soy Isoflavone Intake on Mammographic Density as a Biomarker of Breast Cancer Risk
Globally, breast cancer is the most common cancer and the main cause of deaths due to cancer. This is attributed to changes in reproductive habits as well as an increasingly sedentary lifestyle, with low physical activity and diets rich in saturated fats but low in fiber. While the main focus in many Asian countries is to improve survival from breast cancer by encouraging early detection of the disease and improving access to cancer treatment, it does not reduce the number of women who will be diagnosed with breast cancer in the years to come. Currently, there is an urgent need to develop effective strategies to prevent breast cancer in Asia and beyond.
Soy may be an important dietary strategy for breast cancer prevention. Compared to women in the West, Asian women consume up to 10-fold more soy in their diet, which may, in part, explain their lower risk of breast cancer. Soybeans are rich in isoflavones, which can mimic estrogenic activity. In the body, it competes with estrogen and binds to estrogen receptor sites, thereby reducing the effect of estrogen and possibly lowering breast cancer risk.
Read more
Consistently, research has shown that Asian postmenopausal women who have high soy diets are less likely to be diagnosed with breast cancer. However, researchers have not been able to show that postmenopausal women can reduce their breast cancer risk by increasing soy intake as part of their diets. There are several reasons why these studies have failed to see an effect despite the body of evidence indicating that soy may be protective. Firstly, these are studies of Caucasian women who may have never been exposed to soy, particularly in adolescence, where soy may have the greatest impact. Also, these studies have used soy isoflavone supplements, rather than traditional soy foods made from whole soybeans, which may affect how soy is metabolized in the body. Lastly, the way in which mammographic density measurements were obtained previously could have negatively influenced the study results, such as the use of digitized images of mammogram films rather than raw digital images and the use of semi-automated methods that may be subject to human error and reader variability.
Therefore, a well-designed intervention study among Asian women living in Asia, using suitable mammographic density measures as a surrogate marker of breast cancer risk, will best answer these remaining gaps in our knowledge about the soy-breast cancer relationship.
- Conditions
- Breast Cancer, Mammographic Density
- Being tested
- Dietary soy, Soy Supplement
- Keywords
- Diet, Soy, Prevention, Asian, Breast Cancer, Mammographic Density, Isoflavones
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary soyDietary supplement
Soy isoflavones delivered through diet, assisted by a detailed food guide for locally available soy-based foods.
Soy SupplementDietary supplement
Soy isoflavones delivered in extracted form
| Study group | Role | What they receive |
|---|---|---|
| Dietary Soy Arm | Experimental | Participants will be asked to increase soy in their diet by an equivalent of 50mg/day for 12 months Receives: Dietary Supplement: Dietary soy |
| Soy Supplement Arm | Active comparator | Participants will consume 2 tablets of 50mg each per day for 12 months Receives: Dietary Supplement: Soy Supplement |
| Control Arm | No intervention | No diet or supplement changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammographic Density
Measurement of change in mammographic density over the study period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start19 Nov 2018
- Primary completionApr 2020 (estimated)
- Study completionJun 2020 (estimated)
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.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Research Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham Malaysia, Subang Jaya Medical Centre, Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Soo Hwang Teo, Principal investigator, Cancer Research Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686098
- Sponsor's protocol ID
- CRM-BRE-002
- Acronym
- MiSo
- Status last verified
- Aug 2018
- First submitted
- 25 Sep 2018
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rajaram N, Yap B, Eriksson M, Mariapun S, Tan LM, Sa'at H, Ho ELM, Taib NAM, Khor GL, Yip CH, Ho WK, Hall P, Teo SH. A Randomized Controlled Trial of Soy Isoflavone Intake on Mammographic Density among Malaysian Women. Nutrients. 2023 Jan 6;15(2):299. doi: 10.3390/nu15020299.
PubMed 36678170
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Malaysian Soy and Mammographic Density (MiSo) Study: A Randomized, Three-arm, Controlled Clinical Trial to Investigate the Impact of Soy Isoflavone Intake on Mammographic Density as a Biomarker of Breast Cancer Risk
- ClinicalTrials.gov ID
- NCT03686098
- Acronym / sponsor ID
- MiSo / CRM-BRE-002
- Conditions
- Breast Cancer, Mammographic Density
- Keywords
- Diet, Soy, Prevention, Asian, Breast Cancer, Mammographic Density, Isoflavones
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Cancer Research MalaysiaUniversity, hospital or other
- Collaborators
- University of Nottingham Malaysia, Subang Jaya Medical Centre, Karolinska Institutet
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 26 Sep 2018 (actual)
- 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.
Globally, breast cancer is the most common cancer and the main cause of deaths due to cancer. This is attributed to changes in reproductive habits as well as an increasingly sedentary lifestyle, with low physical activity and diets rich in saturated fats but low in fiber. While the main focus in many Asian countries is to improve survival from breast cancer by encouraging early detection of the disease and improving access to cancer treatment, it does not reduce the number of women who will be diagnosed with breast cancer in the years to come. Currently, there is an urgent need to develop effective strategies to prevent breast cancer in Asia and beyond.
Soy may be an important dietary strategy for breast cancer prevention. Compared to women in the West, Asian women consume up to 10-fold more soy in their diet, which may, in part, explain their lower risk of breast cancer. Soybeans are rich in isoflavones, which can mimic estrogenic activity. In the body, it competes with estrogen and binds to estrogen receptor sites, thereby reducing the effect of estrogen and possibly lowering breast cancer risk.
Consistently, research has shown that Asian postmenopausal women who have high soy diets are less likely to be diagnosed with breast cancer. However, researchers have not been able to show that postmenopausal women can reduce their breast cancer risk by increasing soy intake as part of their diets. There are several reasons why these studies have failed to see an effect despite the body of evidence indicating that soy may be protective. Firstly, these are studies of Caucasian women who may have never been exposed to soy, particularly in adolescence, where soy may have the greatest impact. Also, these studies have used soy isoflavone supplements, rather than traditional soy foods made from whole soybeans, which may affect how soy is metabolized in the body. Lastly, the way in which mammographic density measurements were obtained previously could have negatively influenced the study results, such as the use of digitized images of mammogram films rather than raw digital images and the use of semi-automated methods that may be subject to human error and reader variability.
Therefore, a well-designed intervention study among Asian women living in Asia, using suitable mammographic density measures as a surrogate marker of breast cancer risk, will best answer these remaining gaps in our knowledge about the soy-breast cancer relationship.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dietary Soy Arm | Experimental | Dietary Supplement: Dietary soyParticipants will be asked to increase soy in their diet by an equivalent of 50mg/day for 12 months |
| Soy Supplement Arm | Active comparator | Dietary Supplement: Soy SupplementParticipants will consume 2 tablets of 50mg each per day for 12 months |
| Control Arm | No intervention | –No diet or supplement changes |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Enrolled in the Malaysian Mammography Study and agreed to be contacted
- Aged between 45 and 65 years old at study recruitment (i.e. as of June 2018)
- No genetic predisposition to breast cancer (carriers of the BRCA1 and BRCA2 mutations)
- Measurable amount of mammographic density (at least 4.5% Volpara percent mammographic density).
Key exclusion criteria (15 listed)
- Personal history of breast cancer
- Personal history of other cancers, stroke, and other serious health conditions
- Personal history of benign breast disease
- Pre-menopausal (regular menstrual periods) or early peri-menopausal women (irregular menstrual period with a menstrual period in the past 3 months)
- Women who have a history of high uric acid, gout and associated conditions
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 |
|---|---|---|
| Dietary soySoy isoflavones delivered through diet, assisted by a detailed food guide for locally available soy-based foods. | Dietary supplement | Dietary Soy Arm |
| Soy SupplementSoy isoflavones delivered in extracted form | Dietary supplement | Soy Supplement Arm |
Primary outcome
Mammographic Density
Time frame: 12 months
Measurement of change in mammographic density over the study period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Derived from this study: PubMed 36678170Rajaram N, Yap B, Eriksson M, Mariapun S, Tan LM, Sa'at H, Ho ELM, Taib NAM, Khor GL, Yip CH, Ho WK, Hall P, Teo SH. A Randomized Controlled Trial of Soy Isoflavone Intake on Mammographic Density among Malaysian Women. Nutrients. 2023 Jan 6;15(2):299. doi: 10.3390/nu15020299.
- Official website of Cancer Research MalaysiaLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Soo Hwang Teo principal investigator
Cancer Research Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary soy and Soy Supplement in people with Breast Cancer and Mammographic Density, run by Cancer Research Malaysia at 1 site in Malaysia.
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 15 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: status not confirmed, as of the sponsor's last update on 31 Jan 2019. 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 Malaysia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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 (time frame: 12 months). 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 NCT03686098, 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 31 Jan 2019.