Lifestyle Changes for Breast Cancer

(IMPACT-Women Trial)

Recruiting at 1 trial location

Overseen By Rachel Sherrington, Bkin

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Diabetes, Uncontrolled thyroid, Eating disorder, others

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

Compensation: Varies

Number of Visits: 24

65 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have diabetes and require insulin, you may not be eligible to participate.

What data supports the effectiveness of the treatment Time restricted eating, nutrition education, and sedentary time reduction strategies for breast cancer?

Research shows that lifestyle changes, including diet and physical activity, can help reduce body weight, improve diet quality, and decrease fat intake in breast cancer survivors. These changes are linked to better health outcomes and may lower the risk of cancer recurrence. ^{1 2 3 4 5}

Is time-restricted eating and lifestyle change safe for breast cancer patients?

Time-restricted eating and lifestyle changes like healthy eating and reducing sedentary time are generally considered safe and feasible for breast cancer patients, as they target risk factors common to both breast cancer and cardiovascular disease. ^{2 4 6 7 8}

How is the 'Lifestyle Changes for Breast Cancer' treatment different from other treatments for breast cancer?

This treatment is unique because it focuses on lifestyle changes like time-restricted eating, nutrition education, and reducing sedentary time, rather than traditional medical or surgical interventions. It aims to improve overall health and potentially reduce breast cancer risk by promoting weight management and healthy eating habits. ^{1 9 10 11 12}

What is the purpose of this trial?

Background \& Rationale: Breast cancer (BC) is the most commonly diagnosed malignancy in women worldwide (2.1 million diagnoses in 2018, 25% of new cancer cases). In Canada, early stage BC mortality rates have decreased by 48% over the past 30 years as a result of advances in prevention, detection, and treatment. However, competing risks for mortality from non-cancer causes have emerged, where cardiovascular disease (CVD) is now a leading cause of death for BC survivors. The direct toxic effects of BC treatment on the heart (cardiotoxicity) are well characterized by the investigators and many others, as a contributor to elevated cardiovascular risk. However, BC treatment and the associated lifestyle changes (i.e. physical inactivity, poor diet quality, stress) are increasingly recognized to also strongly affect metabolism negatively manifesting as insulin resistance, dyslipidemia and adipose tissue (fat) accumulation. These adverse metabolic changes are strongly linked to CVD risk and represent a currently underappreciated contributor to the elevated CVD risk among BC survivors. Preliminary data and recent publications demonstrate that regional fat accumulation occurs during BC treatment and that the fat burden in key locations is associated with poor cardiorespiratory health. A trigger of these adverse metabolic and inflammatory effects is excess fat specifically within ectopic fat (viscera, intermuscular, or hepatic) regions. In 2019, a member of the study team found that the volume of visceral and intermuscular but not subcutaneous fat at BC diagnosis were linearly associated with CVD events within 6 years, even among those with normal BMI and after adjustment for pre-existing CVD risk factors and for BC treatment type. Using MRI, investigators found that \~1 year after chemotherapy, BC survivors had significantly larger depots of visceral fat (49% larger) and thigh intermuscular fat (41% larger) compared to age and sex-matched controls, despite similar BMI and subcutaneous fat volumes in the two groups. Investigators also showed that the fat fraction within the thigh muscle and visceral fat volumes independently explained \~50% of the variation in cardiorespiratory fitness (measured by peak VO2). In particular, peak VO2 is one of the most powerful predictors of all-cause and CVD mortality and health care costs, and is the most consistently reported negative sequelae after treatment for BC. Unfortunately, there are no known therapies to recover long-term myocardial damage (i.e. cell death, fibrosis) from cancer therapies. There are several reasons to target fat as a therapeutic target in BC patients: 1) The study team have compelling preliminary data showing accelerated formation of ectopic fat during BC treatment. 2) Investigator's recent data showed that high fat content in key fat pools was associated with reduced peak VO2. 3) The burden of fat and the associated metabolic abnormalities are dynamic and malleable, and thus highly treatable. Research Question \& Objectives: The primary purpose of this study is to evaluate the effect of a behavioural intervention involving supported time-restricted eating (TRE), diet quality improvements, and reduced sedentary time versus usual cancer and nutrition care in BC patients receiving chemotherapy treatment on ectopic fat, cardiometabolic profile, and chemotherapy outcomes. The investigators hypothesize that the intervention will attenuate the growth of ectopic fat during chemotherapy and reduce chemotherapy symptoms.

Research Team

Richard Thompson, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for women over 18 with stage I, II, or III breast cancer who are about to start chemotherapy. They must be able to perform daily activities (ECOG <3), have their oncologist's approval, speak English, and commit to the study intervention.

Inclusion Criteria

I was born female.

I am over 18 years old.

Willing and able to adhere to study intervention

Exclusion Criteria

I have diabetes and need insulin or my A1c is over 10%.

Individuals who do not have access to a smart phone with Bluetooth capability or at least a shared cell phone with someone in the same household

Research MRI contraindications (e.g., pacemaker, magnetic implants, pregnancy)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy Treatment

Participants receive standard chemotherapy treatment along with a behavioral intervention involving time-restricted eating, diet quality improvements, and reduced sedentary time

24 weeks

Regular visits for chemotherapy and intervention monitoring

Follow-up

Participants are monitored for changes in ectopic fat, cardiometabolic profile, and chemotherapy outcomes

2 years

Periodic assessments at baseline, 24 weeks, and 2 years

Long-term Follow-up

Tracking long-term health effects of participation through participants' electronic medical records

Up to 10 years after study completion

Treatment Details

Interventions

• Time restricted eating, nutrition education, and sedentary time reduction strategies

Trial Overview The study tests if a behavioral intervention with time-restricted eating, better diet quality, and less sitting time can reduce fat accumulation and improve heart health compared to standard care in breast cancer patients during chemotherapy.

Participant Groups

Group I: Time-Restricted Eating and Sedentary Time Reduction Experimental Treatment 1 Intervention

Group 1 (Experimental intervention): Participants assigned to this group will receive standard chemotherapy treatment plus a dietary program, and sedentary time reduction strategies, program and a Fitbit monitor. If you are randomized into this group, you will be asked to follow TRE, will receive nutritional education and individualized recommendations on improving diet quality and healthy eating practices, and given to strategies to work towards reducing sedentary time. These components will be gradually introduced over the 24-week program.

Group II: Nutrition and Exercise Guidelines Active Control 1 Intervention

Group 2 (Non-experimental intervention): Participants randomized to this group will receive standard chemotherapy treatment plus a single, group-based "nutrition during cancer" class, as well as a copy of Canada's Food Guide, physical activity guidelines, and a Fitbit monitor. You will be asked to only make dietary changes if they are recommended within the class or by your doctor, and to maintain your usual timing and number of meals consumed per day. Throughout the 24-week period, you will receive seven brief phone calls from a study staff member to ask about your symptoms and provide support. After the end of the study, participants in this group will be offered a one-one-one counselling session with a registered dietitian.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

A systematic review of 51 studies involving 7743 women with breast cancer showed that dietary-based lifestyle interventions significantly reduced body weight, BMI, and fat mass, indicating their efficacy in managing weight and body composition in this population.

These interventions also led to decreased energy and fat intake, along with increased fiber consumption, suggesting that dietary modifications can positively impact nutritional habits in women with breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Dietary-Based Lifestyle Modification Approaches on Anthropometric Indices and Dietary Intake Parameters in Women with Breast Cancer: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Raji Lahiji, M., Vafa, S., de Souza, RJ., et al.[2023]

The LEAN study showed that a 6-month lifestyle intervention for overweight or obese breast cancer survivors significantly improved diet quality, with the intervention group increasing their Healthy Eating Index (HEI) score by 6.8 points compared to 3.1 points in the usual care group.

Participants in the intervention group also achieved greater reductions in total and saturated fat intake, along with increases in fiber and fruit consumption, indicating that weight loss interventions can positively impact dietary habits in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in diet quality in a randomized weight loss trial in breast cancer survivors: the lifestyle, exercise, and nutrition (LEAN) study. Anderson, C., Harrigan, M., George, SM., et al.[2022]

A study of 368 women with breast cancer revealed that most participants made significant dietary changes towards healthier options, such as reducing high-fat and high-sugar foods while increasing fish, fruits, vegetables, and whole grains.

Despite positive dietary changes, only 22.6% of women increased their physical activity, which is important for improving health and potentially reducing the risk of breast cancer recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and physical activity in relation to weight change among breast cancer patients. Yaw, YH., Shariff, ZM., Kandiah, M., et al.[2019]

This study will evaluate the effectiveness of a multimodal intervention combining time-restricted eating, healthy eating, and reduced sedentary time during chemotherapy in 130 women with early-stage breast cancer, focusing on reducing visceral fat accumulation and improving metabolic health.

If successful, the intervention could significantly lower the risk of cardiometabolic diseases and related mortality in breast cancer survivors, highlighting the importance of dietary and lifestyle modifications during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of IMPACT-women: a randomised controlled trial of the effect of time-restricted eating, healthy eating and reduced sedentary behaviour on metabolic health during chemotherapy for early-stage breast cancer. Christensen, RAG., Haykowsky, MJ., Nadler, M., et al.[2023]

A lifestyle intervention involving diet and physical activity led to significant weight loss (5.6 kg) and improvements in body composition among 37 overweight and obese breast cancer survivors who completed the program.

Participants showed substantial reductions in energy and fat intake, along with improvements in quality of life and cardiorespiratory fitness, indicating the intervention's effectiveness in promoting healthier lifestyles post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a diet and physical activity intervention on body weight and nutritional patterns in overweight and obese breast cancer survivors. Travier, N., Fonseca-Nunes, A., Javierre, C., et al.[2021]

In a study involving 172 women undergoing chemotherapy, intermittent energy restriction (IER) showed a trend towards greater weight and body fat reduction compared to continuous energy restriction (CER), particularly after adjusting for body water.

While the overall incidence of severe chemotherapy toxicities was similar between IER and CER, there was a trend indicating fewer severe toxicities in the IER group during later cycles of treatment, suggesting IER may help reduce treatment-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of intermittent vs continuous energy restriction during chemotherapy for early breast cancer. Harvie, M., Pegington, M., Howell, SJ., et al.[2022]

Among 2,741 cancer survivors, 13.8% reported practicing weight-loss restrictive diets, with a higher prevalence in women, those who are overweight/obese, and individuals with breast cancer, indicating a significant trend towards dietary control post-diagnosis.

Fasting was practiced by 6.0% of participants, often associated with the belief that it could improve cancer prognosis; however, those receiving nutritional guidance from healthcare professionals were less likely to engage in fasting or restrictive diets, highlighting the importance of professional dietary advice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fasting and weight-loss restrictive diet practices among 2,700 cancer survivors: results from the NutriNet-Santé cohort. Fassier, P., Srour, B., Raynard, B., et al.[2019]

Time-restricted eating (TRE) is proposed as a safe and feasible lifestyle intervention that could help reduce risk factors for both breast cancer and cardiovascular disease, which share common risk factors like obesity and inflammation.

The review highlights that TRE may provide metabolic and health benefits relevant to both conditions, suggesting it could be an effective strategy for preventing and managing breast cancer and cardiovascular disease in survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating: A Novel and Simple Dietary Intervention for Primary and Secondary Prevention of Breast Cancer and Cardiovascular Disease. Christensen, RAG., Kirkham, AA.[2023]

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]

Weight gain during adulthood increases the risk of developing breast cancer, while weight loss before or after menopause is linked to a lower risk of postmenopausal breast cancer.

Lifestyle changes such as continuous or intermittent energy restriction and exercise, along with potential pharmacological interventions using energy restriction mimetic agents (ERMAs), may help in preventing breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Energy restriction for breast cancer prevention. Howell, A., Chapman, M., Harvie, M.[2019]

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]

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

Effect of Dietary-Based Lifestyle Modification Approaches on Anthropometric Indices and Dietary Intake Parameters in Women with Breast Cancer: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2023]

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

Changes in diet quality in a randomized weight loss trial in breast cancer survivors: the lifestyle, exercise, and nutrition (LEAN) study. [2022]

3. Thailand pubmed.ncbi.nlm.nih.gov

Diet and physical activity in relation to weight change among breast cancer patients. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Rationale and design of IMPACT-women: a randomised controlled trial of the effect of time-restricted eating, healthy eating and reduced sedentary behaviour on metabolic health during chemotherapy for early-stage breast cancer. [2023]

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

Effect of a diet and physical activity intervention on body weight and nutritional patterns in overweight and obese breast cancer survivors. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of intermittent vs continuous energy restriction during chemotherapy for early breast cancer. [2022]

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

Fasting and weight-loss restrictive diet practices among 2,700 cancer survivors: results from the NutriNet-Santé cohort. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating: A Novel and Simple Dietary Intervention for Primary and Secondary Prevention of Breast Cancer and Cardiovascular Disease. [2023]

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

Breast Cancer: A Lifestyle Medicine Approach. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Energy restriction for breast cancer prevention. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Lifestyle Modifications and Breast Cancer Risk. [2023]

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

Lifestyle for breast cancer risk reduction. [2022]