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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether lifestyle changes can assist breast cancer patients during chemotherapy. It will test if time-restricted eating (eating within a specific time window), improved nutrition, and reduced sitting can decrease fat build-up and enhance heart health. Participants will join one of two groups: one follows a structured diet and activity plan, while the other receives general nutrition advice and standard care. Women diagnosed with early to mid-stage breast cancer and starting chemotherapy might be suitable candidates if they are willing to adjust their eating and activity habits. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance cancer care through lifestyle changes.

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 prior data suggests that these lifestyle changes are safe for breast cancer patients?

Research has shown that time-restricted eating (TRE), combined with healthy eating and reduced sedentary behavior, is generally well-tolerated by people with cancer. Studies have found that integrating TRE with these lifestyle changes is both feasible and safe. Specifically, one study discovered that an eight-week period of TRE was manageable for participants and helped lower the risk of heart disease in older breast cancer survivors. These findings suggest that such lifestyle changes can be safely incorporated into the lives of breast cancer patients, potentially leading to better health outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these lifestyle changes for breast cancer because they offer a fresh approach by focusing on time-restricted eating, nutrition education, and reducing sedentary behavior. Unlike traditional treatments that mainly rely on drugs and chemotherapy, these strategies aim to improve overall health and well-being, potentially enhancing the effectiveness of standard treatments. By incorporating a holistic approach with tools like a Fitbit monitor for tracking progress, these interventions could empower patients to actively participate in their health journey, possibly leading to better outcomes and quality of life during treatment.

What evidence suggests that these lifestyle changes could be effective for breast cancer patients?

Research shows that time-restricted eating (TRE) can benefit people with cancer, including those undergoing chemotherapy for breast cancer. In this trial, participants in the "Time-Restricted Eating and Sedentary Time Reduction" arm will follow TRE, receive nutritional education, and work on reducing sedentary time. Studies have found that TRE, combined with healthy eating and increased activity, may improve treatment outcomes and quality of life. Early findings suggest that TRE is not only feasible and acceptable for cancer patients but may also offer cancer-related benefits. This method could aid in weight management and overall health, potentially lowering the risk of heart problems for breast cancer survivors. These lifestyle changes aim to control unwanted fat in specific areas, which is linked to heart health and fitness. ^{1 2 3 5 6}

Who Is on the Research Team?

Richard Thompson, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10404477/

a randomised controlled trial of the effect of time-restricted ... The purpose of this study is to evaluate the effect of a multimodal intervention consisting of TRE, healthy eating, and reduced sedentary time during ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05259410

Time Restricted Eating During Chemotherapy for Breast ... The proposed research will demonstrate that time restricted eating, a form of intermittent fasting, will improve treatment related outcomes, patient related ...

3. academic.oup.com academic.oup.com/nutritionreviews/article/83/7/e1660/7745808

Clinical Impact of Time-restricted Eating on Cancer Preliminary findings suggest that TRE is feasible and acceptable by people with cancer, may have oncological benefits, and improves quality of life.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8537890/

Time-Restricted Eating: A Novel and Simple Dietary ... In composite, these data suggest that TRE may be an easy and novel lifestyle interventions for the primary and secondary prevention of breast cancer, as well as ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0378512224000720

The effects of lifestyle and behavioural interventions on ... This study aimed to assess and compare the effects of lifestyle/behavioural interventions on cancer recurrence, survival and QoL in breast cancer survivors.

6. ahajournals.org ahajournals.org/doi/10.1161/circ.144.suppl_1.12484

Abstract 12484: Weekday 16:8 Time-Restricted Eating in ... Eight weeks of weekday 16:8 TRE is highly feasible, safe, and reduces CVD risk among older breast cancer survivors with overweight/obesity at moderate CVD risk.