Healthy Lifestyle Interventions for Breast Cancer Survivors

(MsFITBC Trial)

Overseen By Amy A Kirkham, PhD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of Toronto

Must not be taking: Tamoxifen, Chemotherapy, Radiation, Hormones

Disqualifiers: Metastatic cancer, Cardiovascular diseases, Diabetes, others

Compensation: Varies

Number of Visits: 3

Duration: 6 months

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how exercise and diet can improve heart health and body composition in women who have survived breast cancer. Participants will be divided into three groups: one will follow a guidelines-based physical activity routine, another will combine exercise with guidelines-based healthy eating advice, and the last group will perform stretching exercises. The aim is to determine if exercise and dietary changes can reduce risks associated with heart disease and diabetes. Women who have had stage I, II, or III breast cancer, are post-menopausal, have a BMI of 25 or more, and have taken aromatase inhibitors in the past may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to important research that could improve health outcomes for breast cancer survivors.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking tamoxifen, receiving chemotherapy, or taking weight loss medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that following exercise guidelines is safe for cancer survivors. Studies have found that survivors can exercise to enhance fitness and quality of life. Exercise routines often include 150 minutes of moderate aerobic activity and muscle strengthening twice a week. This type of activity is well-tolerated and aids in restoring physical function.

For healthy eating, guidelines recommend a diet rich in plant-based foods like fruits, vegetables, whole grains, and nuts. These diets support overall health and are safe for those who have completed cancer treatment. Eating this way can help manage weight and improve overall well-being.

Research strongly supports both exercise and healthy eating as safe and beneficial for cancer survivors aiming to improve their health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the healthy lifestyle interventions being studied for breast cancer survivors because they focus on sustainable, holistic methods that could significantly enhance quality of life. Unlike standard treatments that often focus on medication or surgery, these interventions incorporate guidelines-based physical activity and healthy eating, emphasizing 150 minutes of moderate-intensity exercise and muscle strengthening each week. Additionally, counseling to follow Canada's Food Guide offers personalized nutritional guidance. This approach not only addresses physical health but also empowers survivors with knowledge and habits that promote long-term well-being.

What evidence suggests that this trial's treatments could be effective for breast cancer survivors?

Research shows that exercise benefits breast cancer survivors. Studies have found that exercise boosts physical fitness, improves quality of life, and reduces cancer-related fatigue. In this trial, one group of participants will follow Health Canada's exercise guidelines to enhance overall health.

Another group will combine guidelines-based physical activity with healthy eating, following Canada's Food Guide. Research suggests that this diet, which emphasizes more plant-based foods, lowers the risk of heart and metabolic issues. Eating healthy is crucial for preventing conditions like heart disease and diabetes, which breast cancer survivors are more likely to develop. Together, exercise and healthy eating are believed to improve heart health and body composition in breast cancer survivors. ^{4 6 7 8 9}

Who Is on the Research Team?

Amy A Kirkham, PhD

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

This trial is for breast cancer survivors who lead a sedentary lifestyle and may have metabolic disorders. Participants should be interested in improving their health through exercise or diet.

Inclusion Criteria

I was diagnosed with stage I, II, or III breast cancer after menopause.

High CANRISK score (score of ≥33)

I finished chemotherapy between 1 and 10 years ago.

Exclusion Criteria

Contraindications to research MRI

I have taken tamoxifen before.

Pregnant or breast-feeding currently or in the past 3 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 3-arm RCT for 6 months: 1) exercise following Health Canada guidelines; 2) exercise plus dietary counselling; or 3) stretching group

6 months

Regular visits for exercise and dietary counselling sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up assessments at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Guidelines-based healthy eating
• Guidelines-based physical activity
• Stretching exercise

Trial Overview The study tests the effects of Health Canada's exercise guidelines, these guidelines plus dietary improvements, or just stretching exercises on heart health, body composition, and muscle response to insulin in breast cancer survivors over 6 months.

How Is the Trial Designed?

Group I: Guidelines-based physical activity and healthy eating Experimental Treatment 2 Interventions

Arm Description: 150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening + counselling to follow Canada's Food Guide.

Group II: Guidelines-based physical activity Experimental Treatment 1 Intervention

150 weekly minutes of moderate-intensity aerobic activity and twice weekly whole-body muscle strengthening.

Group III: Stretching exercise Placebo Group 1 Intervention

Whole-body stretching.

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

Interventions aimed at maintaining physical activity in cancer survivors were effective, resulting in a moderate increase in moderate to vigorous physical activity (MVPA) of about 65 minutes per week compared to control groups, which saw an increase of 27 minutes per week.

However, many studies included in the review had biases, primarily involving younger, more active, and well-educated participants, suggesting that future interventions should focus on older adults and those with physical limitations to ensure broader applicability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of maintenance of physical activity behaviour change in cancer survivors. Grimmett, C., Corbett, T., Brunet, J., et al.[2021]

Breast cancer survivors showed no significant differences in overall physical activity levels when comparing in-person cardiovascular rehabilitation (CR) to virtual CR during the COVID-19 pandemic, indicating that virtual options can maintain activity levels.

However, the variability in physical activity duration increased significantly after the transition to virtual CR, suggesting that while overall activity was maintained, the consistency of participation may have been affected, highlighting the need for tailored strategies to enhance engagement in virtual programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer survivors' physical activity and experiences while transitioning to a virtual cardiovascular rehabilitation program during a pandemic (COVID-19). Larkin, J., Vanzella, L., Thomas, S., et al.[2022]

Exercise has been shown to improve key physical health markers in breast cancer survivors, such as peak oxygen consumption, muscle strength, and cardiovascular health, which are linked to better overall health outcomes.

The review will provide recommendations for exercise interventions tailored to breast cancer survivors, highlighting the importance of physical activity in reducing risks of disability and chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinically Relevant Physical Benefits of Exercise Interventions in Breast Cancer Survivors. Kirkham, AA., Bland, KA., Sayyari, S., et al.[2018]

Women with a history of breast cancer who engage in physical activity have a 30% to 50% lower risk of breast cancer recurrence and overall mortality compared to those who are sedentary, based on observational studies.

Small intervention studies indicate that exercise is safe during and after breast cancer treatment, leading to improvements in fitness, strength, and quality of life, prompting organizations like the American Cancer Society to recommend regular moderate-intensity activity for breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of adjuvant and posttreatment exercise programs in breast health. Ligibel, JA.[2019]

Physical activity is linked to a lower risk of developing breast cancer and recurrence, as well as improved survival rates, based on observational studies.

Engaging in physical activity can alleviate treatment-related side effects, such as fatigue from chemotherapy and musculoskeletal issues from aromatase inhibitors, highlighting its importance in breast cancer survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity and Breast Cancer: an Opportunity to Improve Outcomes. Peterson, LL., Ligibel, JA.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06454864

Multiple Risk Factor Intervention Trial in Breast Cancer ... This study aims to produce new evidence on the efficacy of exercise and diet for cardiometabolic risk reduction in BC survivors. Using a 3-arm RCT with to 6 ...

2. bccancer.bc.ca bccancer.bc.ca/nutrition-site/Documents/Patient%20Education/a_nutrition_guide_for_women_with_breast_cancer.pdf

A Nutrition Guide for Women with Breast Cancer Women are recommended to use Eating Well with Canada's Food Guide to plan a plant-based diet. A plant-based diet emphasizes whole grains, fruits, vegetables, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11952977/

Diet quality and cardiometabolic health in breast cancer ... Breast cancer (BC) survivors experience higher rates of cardiometabolic conditions, partly due to treatment. While healthy eating decreases the risk of these ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0022316624003018

Review of Nutrition Guidelines and Evidence on Diet ... This study aimed to review the current nutrition guidelines for cancer survivors in the United States and evaluate the recent evidence from systematic reviews ...

5. mdpi.com mdpi.com/1660-4601/19/13/7579

Healthy Eating and Mortality among Breast Cancer Survivors This systematic review examined the effect of diet quality, defined as adherence to healthy dietary recommendations, on all-cause and breast cancer-specific ...

6. cancer.org cancer.org/cancer/risk-prevention/diet-physical-activity/acs-guidelines-nutrition-physical-activity-cancer-prevention/guidelines.html

American Cancer Society Guideline for Diet and Physical ... The healthiest eating is mostly based on plant foods like vegetables, fruits, whole grains, beans, and nuts/seeds. They also include healthy ...

7. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21721

Nutrition and Physical Activity Guideline for Cancer Survivors Don't be afraid to try new foods. · Choose a variety of plant-based foods. · Try to eat more fruits and vegetables every day. · Try to stay at a ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12423215/

Guidelines on Lifestyle Changes and Breast Cancer ... Breast cancer remains a significant health concern globally, with lifestyle factors playing a crucial role in its prevention and management.

9. mdanderson.org mdanderson.org/content/dam/mdanderson/documents/patients-and-family/becoming-our-patient/while-youre-here/pe-booklets/survivorship/Nutrition.pdf

Survivorship: Nutrition and Physical Activity Guidelines for ... It is best to make healthy food choices and eat a plant-based diet. Research has found that taking supplements may not provide the same health benefit as eating ...