The Malaysian Soy and Mammographic Density Study

NCT ID: NCT03686098

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 282 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-19
• Study Completion Date: 2020-06-30

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.

Conditions

Breast Cancer; Mammographic Density

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Dietary Soy Arm

Participants will be asked to increase soy in their diet by an equivalent of 50mg/day for 12 months

Group Type: EXPERIMENTAL

Dietary soy

Intervention Type: DIETARY_SUPPLEMENT

Soy isoflavones delivered through diet, assisted by a detailed food guide for locally available soy-based foods.

Soy Supplement Arm

Participants will consume 2 tablets of 50mg each per day for 12 months

Group Type: ACTIVE_COMPARATOR

Soy Supplement

Intervention Type: DIETARY_SUPPLEMENT

Soy isoflavones delivered in extracted form

Control Arm

No diet or supplement changes

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dietary soy

Soy isoflavones delivered through diet, assisted by a detailed food guide for locally available soy-based foods.

Intervention Type: DIETARY_SUPPLEMENT

Soy Supplement

Soy isoflavones delivered in extracted form

Intervention Type: DIETARY_SUPPLEMENT

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).

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nottingham Malaysia

OTHER

Sponsor Role: collaborator

Subang Jaya Medical Centre

UNKNOWN

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Cancer Research Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Soo Hwang Teo

Role: PRINCIPAL_INVESTIGATOR

Cancer Research Malaysia

Locations

Cancer Research Malaysia

Subang Jaya, Selangor, Malaysia

Countries

Malaysia

References

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.

Reference Type: DERIVED

PMID: 36678170 (View on PubMed)

Related Links

http://www.cancerresearch.my

Official website of Cancer Research Malaysia

Other Identifiers

CRM-BRE-002

Identifier Type: -

Identifier Source: org_study_id