Lifestyle Changes for Breast Cancer Risk Reduction
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: M.D. Anderson Cancer Center
Disqualifiers: Invasive cancer, Renal disease, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
This trial studies how well a lifestyle intervention works in reducing breast cancer risk through changing body composition and decreasing inflammation in normal weight women. This trial may help researchers learn more about diet and exercise programs designed to decrease body fat in postmenopausal women who are of normal weight but have an elevated risk of breast cancer because of excess body fat.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Lifestyle Intervention, Intensive Lifestyle Intervention, Behavioral Therapy, Dietary Counseling, Physical Activity Intervention for breast cancer risk reduction?
Research shows that lifestyle changes, including a healthy diet and regular physical activity, can lower the risk of developing breast cancer and improve outcomes for those already diagnosed. These interventions can also help reduce the risk of cancer recurrence and improve overall health by managing weight and reducing the risk of other diseases like diabetes and heart disease.12345
Is lifestyle intervention safe for humans?
How is the Lifestyle Intervention treatment for breast cancer risk reduction different from other treatments?
The Lifestyle Intervention treatment is unique because it focuses on making changes to daily habits, such as maintaining a healthy weight, eating a plant-based diet, exercising regularly, and avoiding alcohol, rather than using medication or surgery. This approach aims to prevent breast cancer by addressing lifestyle factors that can reduce risk, which is different from traditional treatments that typically focus on treating the disease after it has developed.238910
Eligibility Criteria
This trial is for postmenopausal women who are of normal weight with a BMI between 18.5 and <25, have excess body fat, no history of invasive cancer except non-melanoma skin cancer, no major surgery within the last 3 months, can exercise safely, and work at MD Anderson Cancer Center but not directly under the study's principal investigator.Inclusion Criteria
No contraindications to exercise (either no positive responses on the Physical Activity Readiness Questionnaire, or clearance from a health care provider certifying that the participant is healthy enough to exercise)
Has internet access on a computer or mobile device
I have not had major surgery in the last 3 months.
See 9 more
Exclusion Criteria
You are currently doing strength exercises that work all major muscle groups two or more times per week.
MD Anderson employees that report to the principal investigator of this study
Participants that cannot engage in the exercise program for more than three weeks during the study period
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Lifestyle Intervention
Participants complete lifestyle intervention consisting of high-resistance circuit training, aerobic training, and diet recommendations for 16 weeks
16 weeks
Weekly sessions with health coach or dietitian
Wait-list
Participants are placed on a wait-list before starting the lifestyle intervention
16 weeks
Follow-up
Participants are monitored for safety and effectiveness after the intervention
4 weeks
Treatment Details
Interventions
- Lifestyle Intervention (Behavioural Intervention)
Trial OverviewThe trial tests if lifestyle changes like diet control and physical activities (resistance training and aerobic exercises) can reduce breast cancer risk by decreasing body fat and inflammation in normal-weight women with high breast cancer risk due to excess body fat.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (lifestyle intervention)Experimental Treatment5 Interventions
Participants complete lifestyle intervention consisting of 1-3 sets of high-resistance circuit training sessions per week, up to 150 minutes of aerobic training per week, and diet recommendations from a health coach or registered dietitian twice per week for 16 weeks.
Group II: Group II (wait-list, lifestyle intervention)Active Control5 Interventions
Participants are placed on a wait-list and then complete lifestyle intervention after 4 months.
Lifestyle Intervention is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Lifestyle Intervention for:
- Obesity
- Weight Loss
- Type 2 Diabetes Prevention
🇪🇺 Approved in European Union as Lifestyle Intervention for:
- Obesity
- Overweight
- Weight-Related Diseases
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
Foundation for Women's CancersCollaborator
References
Weight Management and Physical Activity for Breast Cancer Prevention and Control. [2019]Observational evidence has consistently linked excess adiposity and inactivity to increased breast cancer risk and to poor outcomes in individuals diagnosed with early-stage, potentially curable breast cancer. There is less information from clinical trials testing the effect of weight management or physical activity interventions on breast cancer risk or outcomes, but a number of ongoing trials will test the impact of weight loss and other lifestyle changes after cancer diagnosis on the risk of breast cancer recurrence. Lifestyle changes have additional benefits beyond their potential to decrease primary or secondary breast cancer risk, including improvements in metabolic parameters, reduction in the risk of comorbidities such as diabetes and heart disease, improvement of physical functioning, and mitigation of side effects of cancer therapy. Despite these myriad benefits, implementation of lifestyle interventions in at-risk and survivor populations has been limited to date. This article reviews the evidence linking lifestyle factors to breast cancer risk and outcomes, discusses completed and ongoing randomized trials testing the impact of lifestyle change in primary and secondary breast cancer prevention, and reviews efforts to implement and disseminate lifestyle interventions in at-risk and breast cancer survivor populations.
Breast Cancer: A Lifestyle Medicine Approach. [2021]Breast cancer is the most common female cancer diagnosis in the United States (excluding skin cancers), and the second leading cause of female cancer death. This article highlights the role that lifestyle plays in primary breast cancer prevention, breast cancer treatment, and tertiary breast cancer prevention. Current data regarding the benefits of a predominantly plant-based diet in combination with physical activity and maintenance of a healthy body weight will be reviewed. The evidenced-based patient-focused recommendations developed by the World Cancer Research Fund/American Institute for Cancer Research will be discussed in the context of an overall lifestyle strategy. It is our hope that this publication empowers clinicians to provide patients with personalized cancer-protective lifestyle prescriptions.
Lifestyle Intervention for Breast Cancer Women. [2020]Breast cancer patients have various physical, psychological health risks, among which are the effects on general health. Lifestyle intervention involving nutrition education, physical activity, and stress management, and has been shown to be effective in improving the health of breast cancer patients. Therefore, it is necessary to develop and apply a lifestyle intervention program to promote health in breast cancer patients.
Association of Healthy Diet and Physical Activity With Breast Cancer: Lifestyle Interventions and Oncology Education. [2022]Global cancer statistics suggest that breast cancer (BC) is the most diagnosed cancer in women, with an estimated 2. 3 million new cases reported in 2020. Observational evidence shows a clear link between prevention and development of invasive BC and lifestyle-based interventions such as a healthy diet and physical activity. The recent findings reveal that even minimal amounts of daily exercise and a healthy diet reduced the risk of BC, mitigated the side effects of cancer treatment, and stopped the recurrence of cancer in the survivors. Despite the myriad benefits, the implementation of these lifestyle interventions in at-risk and survivor populations has been limited to date. Given the need to disseminate information about the role of physical activity and nutrition in BC reduction, the review aimed to present the recent scientific outreach and update on associations between the lifestyle interventions and BC outcomes to narrow the gap and strengthen the understanding more clearly. This review covers more direct, detailed, and updated scientific literature to respond to frequently asked questions related to the daily lifestyle-based interventions and their impact on BC risk and survivors. This review also highlights the importance of the oncology provider's job and how oncology education can reduce the BC burden.
The German SUCCESS C Study - The First European Lifestyle Study on Breast Cancer. [2022]SUMMARY: Cohort trials have shown evidence that obesity and a low level of physical activity are not only associated with a higher risk of developing breast cancer, but also with an increased risk for recurrence and reduced survival in breast cancer patients. The SUCCESS C study is the first European trial to evaluate the effect of an intensive lifestyle intervention program on disease-free survival in women with early breast cancer and to examine the predictive value of selected biomarker candidates. A total of 3,547 women with early-stage, Her2/neu-negative breast cancer will be included. The first randomization will compare disease-free survival in patients treated with either 3 cycles of FEC (epirubicine, fluorouracil, cyclophosphamide), followed by 3 cycles of docetaxel or 6 cycles of docetaxel-cyclophosphamide, and thus assess the role of anthracycline-free chemotherapy. The second randomization compares disease-free survival in patients with a body mass index of 24-40 kg/m(2) receiving either a telephone-based individualized lifestyle intervention program aiming at moderate weight loss or general recommendations for a healthy lifestyle alone. In addition, the study will evaluate the predictive role of cancer-associated and obesity-related biomarkers for the prediction of disease recurrence and survival. This SUCCESS C trial will provide valuable information on the effects of a lifestyle intervention program on the prognosis of early breast cancer patients.
A Diet and Exercise Intervention during Chemotherapy for Breast Cancer. [2021]Weight gain is an important concern that impacts on breast cancer outcomes and general health in survivorship. This randomized, pilot study evaluated whether or not women could comply with a weight control program that is initiated at the beginning of chemotherapy for breast cancer. The program sought to prevent weight gain using a low-fat, high fruit-vegetable diet combined with moderate physical activity. The intervention was implemented using a telephone counseling approach that blended motivational interviewing with social cognitive theory. A total of 40 women were recruited over 9 months at the University of Michigan Comprehensive Cancer Center. This represents 55% of eligible women referred to the study and indicates that interest in a healthy lifestyle program at the initiation of chemotherapy for breast cancer was high. Subjects who dropped out had significantly lower fruit and vegetable intakes and lower blood carotenoids at baseline than subjects who completed the study. Statistically significant beneficial effects were observed on fruit and vegetable intakes, physical activity and breast cancer-specific well-being by the intervention. Mean body fat from dual energy X-ray absorptiometry increased in the written materials arm and decreased in the intervention arm. Of the enrolled women, 75% completed 12 months on study and satisfaction with study participation was high. These data indicate that lifestyle intervention during breast cancer treatment is feasible during treatment with chemotherapy for breast cancer and benefits women in several domains.
The Breast Cancer Weight Loss trial (Alliance A011401): A description and evidence for the lifestyle intervention. [2023]The Breast Cancer Weight Loss (BWEL) trial is a randomized controlled trial designed to determine whether weight loss after a breast cancer diagnosis can reduce the risk of cancer recurrence in women with overweight or obesity. The BWEL trial will compare the efficacy of a telephone-based weight-loss intervention plus health education materials versus health education materials alone on invasive disease-free survival in 3,181 women with stage II or III breast cancer and BMI > 27 kg/m2 . This report provides a detailed description of the goals and methods of the lifestyle intervention and the evidence supporting the intervention used in the BWEL trial. The intervention's primary goal for participants is to achieve and maintain a weight loss ≥ 10% of baseline weight through increased physical activity and caloric restriction. The evidence supporting the diet, physical activity, and behavioral components of this telephone-based weight-loss intervention, as well as strategies to promote participant engagement and retention, is described. The intervention is provided through 42 sessions delivered by trained health coaches over a 2-year period. If the BWEL lifestyle intervention is successful in improving cancer outcomes, then weight loss will be incorporated into the care of thousands of breast cancer patients.
Can diet and lifestyle prevent breast cancer: what is the evidence? [2022]Breast cancer is the most common cancer among women in both developed and less-developed countries. Rates of breast cancer are increasing worldwide, with a particular increase in postmenopausal and estrogen receptor-positive cases. The World Cancer Research Fund (WCRF) and American Cancer Society (ACS) cancer prevention guidelines recommend maintaining a healthy weight, undertaking at least 150 minutes of moderate intensity exercise per week, limiting alcohol consumption, and eating a plant-based diet. Observational data link adherence to physical activity and alcohol guidelines throughout life to a reduced risk of developing pre- and postmenopausal breast cancer. Weight control throughout life appears to prevent cases after menopause. Adherence to a healthy dietary pattern does not have specific effects on breast cancer risk but remains important as it reduces the risk for other common diseases, such as cardiovascular disease (CVD), diabetes, and dementia. Emerging data suggest that smoking during adolescence or early adulthood increases later risk of breast cancer. Lifestyle factors appear to modify risk among high-risk women with a family history and those with typical risk of the general population, although their effects among carriers of BRCA mutations are not well defined. Recent expert reports estimate that successful lifestyle changes could prevent 25% to 30% of cases of breast cancer. These reductions will only be achieved if we can implement targeted prevention programs for high-risk women and women in population-based breast screening programs during childhood, adolescence, and early adulthood when the rapidly developing breast is particularly susceptible to carcinogenesis.
Lifestyle for breast cancer risk reduction. [2022]Primary prevention is the most cost-effective long-term strategy for reducing breast cancer occurrence. Lifestyle education centered on the 2018 American Institute for Cancer Research Cancer Prevention Recommendations, offered as a package, should be a core component of routine patient visits. The key components of the recommendations include maintenance of a normal weight; following a low-fat, whole-food, plant-predominant diet rich in whole grains, fruit, and vegetables; regular physical activity; and alcohol avoidance.
Influence of lifestyle factors on breast cancer risk. [2020]Breast Cancer (BC) is a life-changing event. Compared to other malignancies in women, BC has received considerably more public attention. Despite improved neoadjuvant, adjuvant, and palliative treatment strategies for each characteristic molecular BC subtype, recommendations for evidence-based preventive strategies for BC treatment are not given equivalent attention. This may be partly due to the fact that high-quality long-term prevention studies are still difficult to carry out and are thus underrepresented in international studies. The aim of this review is to discuss the most relevant lifestyle factors associated with BC and to identify and discuss the evidence supporting practical prevention strategies that can be used in everyday clinical practice.