Lifestyle Changes to Prevent Breast Cancer

Overseen By Lorenzo Cohen, PHD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Cancer history, Thought disorders, Diabetes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 26

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether lifestyle changes can help prevent breast cancer. Participants will follow a program called Comprehensive Lifestyle Change, which includes healthy eating, regular exercise, stress management, and mindfulness practices. The study will compare this program to a group that does not make these changes. Women with intact breasts and ovaries, who are premenopausal, have a higher body mass index (BMI of 25 or more), and engage in minimal physical and mind-body activities are good candidates for the trial. Participants must be able to attend sessions at the University of Texas MD Anderson. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on lifestyle changes and breast cancer prevention.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that individuals taking tamoxifen, arimidex, or other hormonal prevention strategies can still participate.

What prior data suggests that this comprehensive lifestyle change is safe for preventing breast cancer?

Research has shown that making significant lifestyle changes is usually safe for most people. Studies have found that improvements such as better nutrition, increased exercise, and stress management are generally well-tolerated. For instance, one study found that participants in a lifestyle program lost about 3–4% of their weight over two years without major side effects.

Another study suggested that following lifestyle recommendations can benefit breast cancer survivors, indicating safety and positive health outcomes. These changes include healthier eating, increased activity, and improved stress management.

Overall, while lifestyle changes are often safe and beneficial, consulting a healthcare provider before starting any new program is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comprehensive lifestyle changes for breast cancer prevention because they focus on empowering individuals with proactive habits rather than relying solely on medical interventions. This approach includes a blend of physical activity, nutrition, diet, and mind-body practices, which are personalized and holistic compared to more conventional treatments like medication or surgery. By integrating behavioral counseling, this method seeks to foster sustainable, long-term wellness and potentially reduce the risk of developing breast cancer.

What evidence suggests that comprehensive lifestyle change might be an effective prevention for breast cancer?

This trial will compare a comprehensive lifestyle change program with no intervention to assess its impact on breast cancer prevention. Studies have shown that significant lifestyle changes can help prevent breast cancer. Evidence suggests that increased physical activity can lower breast cancer risk by about 10%. Research also indicates that changes in diet and exercise can help women maintain a healthier weight, which is linked to a lower cancer risk. Additionally, lifestyle medicine approaches can benefit those already living with breast cancer by improving overall health. This program focuses on key areas like diet, exercise, and stress, all crucial for reducing cancer risk. ^{1 2 4 5 6}

Who Is on the Research Team?

Lorenzo Cohen

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for premenopausal women with a BMI of 25 or higher, who have intact breasts and ovaries, can read and speak English, have internet access, and can visit UT MD Anderson for sessions. They should eat few fruits/veggies, exercise less than 150 minutes per week, rarely practice mind-body techniques. Excluded are those with any cancer history (except non-melanoma skin cancers), current pregnancy or plans to become pregnant soon.

Inclusion Criteria

Able to provide informed consent to participate in the study

Access to internet connection

I have not gone through menopause.

Exclusion Criteria

Communication barriers (e.g. hard of hearing)

I am not planning any new drug or preventive surgery for breast cancer within a year, but I may be on tamoxifen or arimidex.

I have had cancer before, but not skin cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend IO prevention program with physical activity, nutrition, and mind-body practice sessions weekly for 12 weeks, and behavioral counseling sessions weekly for up to 26 weeks

26 weeks

Weekly sessions

Crossover

Patients in Group II may crossover to Group I after 26 weeks

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Follow-up at 26 weeks and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Comprehensive Lifestyle Change

Trial Overview The study tests if a comprehensive lifestyle change program including diet advice, physical activity, stress management/mindfulness training, sleep hygiene techniques and behavioral counseling plus social support can prevent breast cancer in at-risk premenopausal women.

How Is the Trial Designed?

Group I: Group I (IO prevention program) Experimental Treatment 2 Interventions

Patients attend IO prevention program consisting of 1-2 physical activity, nutrition and diet, and mind-body practice sessions over 60 minutes weekly for 12 weeks. Patients also attend a behavioral counseling session once weekly for up to 26 weeks. Patients complete exercises over 30-60 minutes 3-5 times weekly for 12 weeks.

Group II: Group II (no intervention) Active Control 1 Intervention

Patients receive no intervention. After 26 weeks, patients may crossover to Group I.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Lifestyle modifications can significantly reduce the risk of breast cancer, highlighting the importance of healthy habits in cancer prevention.

The review emphasizes that changes in diet, physical activity, and weight management are key factors in lowering breast cancer incidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle Modifications and Breast Cancer Risk. Manni, A., El-Bayoumy, K.[2023]

Maintaining a healthy lifestyle, including regular exercise, weight control, and a plant-based diet, can significantly reduce the risk of developing breast cancer, particularly in postmenopausal women.

Implementing targeted prevention programs for high-risk women and promoting healthy habits during childhood and adolescence could potentially prevent 25% to 30% of breast cancer cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can diet and lifestyle prevent breast cancer: what is the evidence? Harvie, M., Howell, A., Evans, DG.[2022]

Excess body fat and inactivity are linked to a higher risk of developing breast cancer and poorer outcomes for those diagnosed with early-stage breast cancer, highlighting the importance of lifestyle factors in cancer risk.

Ongoing clinical trials are exploring how weight management and physical activity after a breast cancer diagnosis can potentially reduce the risk of recurrence, while also providing additional health benefits like improved metabolism and reduced risk of other diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Management and Physical Activity for Breast Cancer Prevention and Control. Ligibel, JA., Basen-Engquist, K., Bea, JW.[2019]

Implementing lifestyle education based on the 2018 American Institute for Cancer Research recommendations is a cost-effective strategy for the primary prevention of breast cancer.

Key lifestyle changes include maintaining a healthy weight, adopting a low-fat, plant-based diet, engaging in regular physical activity, and avoiding alcohol, which should be integrated into routine patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle for breast cancer risk reduction. Mussallem, D.[2022]

Breast cancer (BC) has received significant public attention, but evidence-based preventive strategies are not as well emphasized, despite advancements in treatment for various BC subtypes.

The review aims to highlight key lifestyle factors linked to BC and provide practical prevention strategies that can be implemented in clinical practice, addressing the gap in long-term prevention studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of lifestyle factors on breast cancer risk. Dieterich, M., Stubert, J., Reimer, T., et al.[2020]

The CompLife trial, involving 55 women with stage III breast cancer, demonstrated that a comprehensive lifestyle change intervention focusing on diet, exercise, and mind-body practices is feasible and well-received, with high adherence rates (95% for in-person sessions and 88% for video counseling).

Qualitative feedback from participants highlighted the positive impact of the intervention on their lifestyle and well-being, particularly emphasizing the benefits of the mind-body component and social support, suggesting potential for improved disease-free survival and overall patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comprehensive Lifestyle Randomized Clinical Trial: Design and Initial Patient Experience. Arun, B., Austin, T., Babiera, GV., et al.[2018]

A predominantly plant-based diet, along with regular physical activity and maintaining a healthy weight, plays a crucial role in preventing breast cancer and supporting treatment.

The article emphasizes the importance of personalized lifestyle recommendations for patients, based on evidence from the World Cancer Research Fund/American Institute for Cancer Research, to enhance cancer prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast Cancer: A Lifestyle Medicine Approach. Orman, A., Johnson, DL., Comander, A., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5558265/

A Comprehensive Lifestyle Randomized Clinical Trial The primary outcome is disease-free survival. Multiple secondary outcomes are being evaluated, including: (1) biological pathways; (2) overall survival; (3) ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0261561424002310

Effect of a comprehensive lifestyle intervention program on ... The results of this study show that a 24-month, individualized, telephone-delivered lifestyle intervention led to a moderate weight loss of 3–4% in women with ...

3. academic.oup.com academic.oup.com/oncolo/article/30/7/oyae303/7915797

Evidence for the benefits of lifestyle medicine interventions in ... Data presented here suggest that patients living with breast cancer would benefit from a comprehensive lifestyle medicine approach to ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/17437199.2025.2539202

Full article: Maintenance of lifestyle changes following ... Randomised controlled trials assessing the effectiveness of lifestyle interventions among breast cancer survivors reporting outcomes (physical (in)activity, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6350793/

Lifestyle Interventions for Breast Cancer Prevention - PMC Higher levels of self-reported physical activity were associated with a 10% relative risk reduction in breast cancer risk, compared to a lower self-reported ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2804477

Adherence to Cancer Prevention Lifestyle ... This cohort study investigates whether adherence to overlapping cancer prevention lifestyle recommendations before, during, and after ...