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

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, but you cannot participate if you are currently taking tamoxifen, receiving chemotherapy, or taking weight loss medications.

What data supports the effectiveness of this treatment for breast cancer survivors?

Research suggests that following healthy lifestyle guidelines, including diet and exercise, can improve quality of life, sleep quality, and reduce anxiety in breast cancer survivors. Additionally, maintaining physical activity may help reduce cancer recurrence and improve overall health and wellbeing. ^{1 2 3 4 5}

Is it safe for breast cancer survivors to participate in healthy lifestyle interventions like exercise and physical activity?

Research shows that physical activity is generally safe for breast cancer survivors and can be performed during and after treatment. Exercise has been associated with improvements in fitness, strength, and quality of life, and is encouraged by health organizations for most breast cancer survivors. ^{6 7 8 9 10}

How is the 'Healthy Lifestyle Interventions for Breast Cancer Survivors' treatment different from other treatments for breast cancer survivors?

This treatment is unique because it focuses on lifestyle changes, such as healthy eating and regular physical activity, based on guidelines, rather than medication. It aims to improve overall health, quality of life, and potentially reduce cancer recurrence by encouraging breast cancer survivors to adopt and maintain healthy habits. ^{2 5 11 12 13}

What is the purpose of this trial?

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 months of 1) exercise following Health Canada guidelines; 2) the same exercise plus counselling to follow Canada's Dietary Guidelines to improve diet quality; or 3) stretching group, this study will answer the following questions: * What is the impact of exercise on cardiometabolic health and body composition in BC survivors? * What is the effect modification of adding a diet quality intervention to exercise on cardiometabolic health and body composition? * Is there a link between the capacity of skeletal muscle adaptation to exercise (and diet) and insulin resistance in BC survivors? The investigators hypothesize that: 1) exercise will improve cardiometabolic and body composition outcomes 2) improvements in cardiometabolic outcomes will be enhanced by the addition of diet quality, which will be essential or additive for Matsuda index, metabolic syndrome, Framingham CVD risk, thigh myosteatosis, muscle mass, VO2peak, 3) skeletal muscle insulin signalling transduction will be impaired in BC survivors via dampened expression of insulin-responsive proteins (e.g. GLUT4) and co-occur with impaired muscle quality (e.g., higher rates of fat depots, presence of fibrous tissue) negatively impacting insulin signalling.

Research Team

Amy A Kirkham, PhD

Principal Investigator

University of Toronto

Eligibility Criteria

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.

I finished chemotherapy between 1 and 10 years ago.

High CANRISK score (score of ≥33)

Exclusion Criteria

Contraindications to research MRI

I have taken tamoxifen before.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

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

Impact of nutrition and exercise on cancer survival. [2008]

2. Spain pubmed.ncbi.nlm.nih.gov

[Interventions to improve healthy lifestyles and their effects on psychological variables among breast cancer survivors: a systematic review]. [2018]

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

Systematic review and meta-analysis of maintenance of physical activity behaviour change in cancer survivors. [2021]

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

Clinically Relevant Physical Benefits of Exercise Interventions in Breast Cancer Survivors. [2018]

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

Effect of healthy diet and exercise on chemotherapy completion rate in women with breast cancer: The Lifestyle, Exercise and Nutrition Early after Diagnosis (LEANer) study: Study protocol for a randomized clinical trial. [2023]

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

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

7. Germany 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). [2022]

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

Physical Activity and Breast Cancer: an Opportunity to Improve Outcomes. [2019]

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

Clinical factors associated with adherence to aerobic and resistance physical activity guidelines among cancer prevention patients and survivors. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Determinants of adherence to physical activity guidelines among overweight and obese African American breast cancer survivors: implications for an intervention approach. [2022]

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

Survivorship: healthy lifestyles, version 2.2014. [2022]

12. China pubmed.ncbi.nlm.nih.gov

[Guidelines on life-style modification for Chinese breast cancer survivors]. [2018]

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

Wellness Coaching: An Intervention to Increase Healthy Behavior in Breast Cancer Survivors. [2021]