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

60 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Comprehensive Lifestyle Change in preventing breast cancer?

Research shows that lifestyle changes, like maintaining a healthy weight and staying active, can lower the risk of breast cancer and improve outcomes for those already diagnosed. These changes also help with other health issues, such as diabetes and heart disease, and improve overall well-being. ^{1 2 3 4 5}

Is the lifestyle change treatment generally safe for humans?

Lifestyle changes, such as weight management and physical activity, are generally safe and can improve overall health by reducing the risk of other conditions like diabetes and heart disease, and improving physical functioning. ^{1 2 5 6 7}

How is the Comprehensive Lifestyle Change treatment different from other breast cancer treatments?

The Comprehensive Lifestyle Change treatment is unique because it focuses on lifestyle modifications, such as a plant-based diet, regular exercise, and maintaining a healthy weight, rather than traditional medical treatments. This approach aims to prevent breast cancer by addressing risk factors through everyday habits. ^{2 6 8 9 10}

What is the purpose of this trial?

This trial studies how well comprehensive lifestyle change works in preventing patients from breast cancer. A program including dietary recommendations, physical activity, stress management and mindfulness training, learning sleep hygiene techniques, and behavioral counseling in addition to social support may help patients who may be at risk for breast cancer.

Research Team

Lorenzo Cohen

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Weight Management and Physical Activity for Breast Cancer Prevention and Control. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Breast Cancer: A Lifestyle Medicine Approach. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Rationale and description of a lifestyle intervention programme to achieve moderate weight loss in women with non-metastatic breast cancer: the lifestyle intervention part of the SUCCESS C Study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of obesity and other lifestyle factors on mortality in women with breast cancer. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A Comprehensive Lifestyle Randomized Clinical Trial: Design and Initial Patient Experience. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Lifestyle Modifications and Breast Cancer Risk. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Optimisation of the ActWELL lifestyle intervention programme for women attending routine NHS breast screening clinics. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Can diet and lifestyle prevent breast cancer: what is the evidence? [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Influence of lifestyle factors on breast cancer risk. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Lifestyle for breast cancer risk reduction. [2022]