65 Participants Needed

Lifestyle Changes for Breast Cancer

(IMPACT-Women Trial)

Recruiting at 1 trial location
RS
Overseen ByRachel Sherrington, Bkin
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Alberta
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.24678

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.19101112

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

RT

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
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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)
See 6 more

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
2Treatment groups
Experimental Treatment
Active Control
Group I: Time-Restricted Eating and Sedentary Time ReductionExperimental Treatment1 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 GuidelinesActive Control1 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.

Find a Clinic Near You

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

References

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]
Changes in diet quality in a randomized weight loss trial in breast cancer survivors: the lifestyle, exercise, and nutrition (LEAN) study. [2022]
Diet and physical activity in relation to weight change among breast cancer patients. [2019]
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]
Effect of a diet and physical activity intervention on body weight and nutritional patterns in overweight and obese breast cancer survivors. [2021]
Randomised controlled trial of intermittent vs continuous energy restriction during chemotherapy for early breast cancer. [2022]
Fasting and weight-loss restrictive diet practices among 2,700 cancer survivors: results from the NutriNet-Santé cohort. [2019]
Time-Restricted Eating: A Novel and Simple Dietary Intervention for Primary and Secondary Prevention of Breast Cancer and Cardiovascular Disease. [2023]
Breast Cancer: A Lifestyle Medicine Approach. [2021]
Energy restriction for breast cancer prevention. [2019]
Lifestyle Modifications and Breast Cancer Risk. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Lifestyle for breast cancer risk reduction. [2022]
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