The Malaysian Soy and Mammographic Density Study (MiSo)
Primary Purpose
Breast Cancer, Mammographic Density
Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Dietary soy
Soy Supplement
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring Diet, Soy, Prevention, Asian, Breast Cancer, Mammographic Density, Isoflavones
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
- 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).
Sites / Locations
- Cancer Research Malaysia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Dietary Soy Arm
Soy Supplement Arm
Control Arm
Arm Description
Participants will be asked to increase soy in their diet by an equivalent of 50mg/day for 12 months
Participants will consume 2 tablets of 50mg each per day for 12 months
No diet or supplement changes
Outcomes
Primary Outcome Measures
Mammographic Density
Measurement of change in mammographic density over the study period
Secondary Outcome Measures
Full Information
NCT ID
NCT03686098
First Posted
September 25, 2018
Last Updated
January 29, 2019
Sponsor
Cancer Research Malaysia
Collaborators
University of Nottingham Malaysia, Subang Jaya Medical Centre, Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT03686098
Brief Title
The Malaysian Soy and Mammographic Density Study
Acronym
MiSo
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 19, 2018 (Actual)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Research Malaysia
Collaborators
University of Nottingham Malaysia, Subang Jaya Medical Centre, Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Mammographic Density
Keywords
Diet, Soy, Prevention, Asian, Breast Cancer, Mammographic Density, Isoflavones
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
282 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dietary Soy Arm
Arm Type
Experimental
Arm Description
Participants will be asked to increase soy in their diet by an equivalent of 50mg/day for 12 months
Arm Title
Soy Supplement Arm
Arm Type
Active Comparator
Arm Description
Participants will consume 2 tablets of 50mg each per day for 12 months
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
No diet or supplement changes
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary soy
Intervention Description
Soy isoflavones delivered through diet, assisted by a detailed food guide for locally available soy-based foods.
Intervention Type
Dietary Supplement
Intervention Name(s)
Soy Supplement
Intervention Description
Soy isoflavones delivered in extracted form
Primary Outcome Measure Information:
Title
Mammographic Density
Description
Measurement of change in mammographic density over the study period
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soo Hwang Teo
Organizational Affiliation
Cancer Research Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Research Malaysia
City
Subang Jaya
State/Province
Selangor
ZIP/Postal Code
47500
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://www.cancerresearch.my
Description
Official website of Cancer Research Malaysia
Learn more about this trial
The Malaysian Soy and Mammographic Density Study
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