Lifestyle Changes for Breast Cancer

Overseen By Melinda Irwin

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Pregnancy, Dementia, Major psychiatric disease, others

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

Compensation: Varies

Number of Visits: 14

Duration: 24 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special program combining nutrition advice and exercise can help women with triple-negative breast cancer (TNBC) respond better to chemotherapy before surgery. The main goal is to determine if these lifestyle changes can lead to a pathologic complete response, meaning no cancer is found in the breast after treatment. Participants will either follow this program or continue with their usual care. Women with stage II or III TNBC, who are about to start chemo-immunotherapy (a combination of chemotherapy and immunotherapy), and who aren't currently exercising much or eating many fruits and vegetables might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to explore innovative lifestyle changes that could enhance treatment outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor or the trial coordinators.

What prior data suggests that this nutrition and exercise program is safe for women with triple-negative breast cancer?

Research has shown that combining exercise and a healthy diet can be safe and beneficial for breast cancer patients. Studies indicate that exercising during treatment reduces fatigue and pain and improves overall quality of life. Evidence also suggests that regular physical activity may lower the chances of cancer recurrence and reduce the risk of cancer-related death.

Recent guidelines confirm that exercise is safe during chemotherapy. However, whether exercise helps patients handle chemotherapy better remains uncertain. Increased activity and maintaining a healthy weight have been linked to better adherence to chemotherapy, meaning patients are more likely to complete their treatment as planned.

Overall, treatment that includes exercise and good nutrition appears well-tolerated, with no major safety concerns reported in previous studies. These findings suggest that patients can safely adopt these lifestyle changes while undergoing cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LEAN Trial because it's exploring how lifestyle changes, specifically through exercise and medical nutrition, could enhance breast cancer treatment. Unlike standard treatments that focus solely on medical interventions like chemotherapy, this approach integrates physical activity and nutrition counseling as part of the care plan. This trial is unique because it offers personalized support through virtual sessions and check-ins, aiming to empower patients and potentially improve outcomes by addressing overall well-being during the treatment process. By focusing on these lifestyle factors, researchers hope to discover if these changes can make a significant difference in patient recovery and treatment effectiveness.

What evidence suggests that this nutrition and exercise program is effective for improving pathologic complete response in triple-negative breast cancer?

Research shows that exercise and healthy eating can benefit individuals undergoing breast cancer treatment. In this trial, participants in the "Exercise and Medical Nutrition" arm will receive an exercise and nutrition program alongside their chemotherapy. One study found that women with breast cancer who began chemotherapy and followed a similar program experienced significant health and fitness improvements. These improvements can enhance the body's response to cancer treatments. Exercise also correlates with a better quality of life and improved physical abilities in breast cancer patients. Although the effects on triple-negative breast cancer (TNBC) are not fully understood, these findings suggest that such programs might improve treatment outcomes. ^{4 6 7 8 9}

Who Is on the Research Team?

Melinda Irwin

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for women over 18 with stage II or III Triple Negative Breast Cancer who exercise less than 150 minutes per week, eat fewer than 7 fruits and veggies weekly, can walk, read English, and have not started their second chemo cycle. They must get clearance from their oncologist to join.

Inclusion Criteria

Not exercising (less than 150 min/week)

Able to complete forms, understand instructions, and read in English

Agree to be randomly assigned to either group

Exclusion Criteria

Pregnancy or intention to become pregnant

Presence of dementia or major psychiatric disease

I have not had a stroke, heart attack, or heart failure in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo baseline assessments including surveys, blood draw, 6-minute walk test, and DXA scan

1 week

1 visit (in-person)

Treatment

Participants receive neoadjuvant chemo-immunotherapy with weekly remote nutrition and exercise counseling sessions

24 weeks

10 remote sessions, additional remote check-ins

Surgery

Participants undergo surgery to assess pathologic complete response

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of residual cancer burden and other health metrics

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• LEAN Trial

Trial Overview The LEAN trial is testing if a program of nutrition and exercise can lead to no visible cancer in the breast (pCR) after chemotherapy in women with TNBC. Participants will be randomly placed into two groups: one following the program and the other not.

How Is the Trial Designed?

Group I: Exercise and Medical Nutrition Experimental Treatment 1 Intervention

Women randomized to the intervention will receive 10, 30-minute sessions spread out over the course of their neoadjuvant therapy and in the weeks leading up to surgery. In weeks in which one of the 10 counseling sessions is not scheduled the interventionist will observe the participant in an exercise session via zoom, or check in with the participant by phone regarding their exercise. The intervention will continue until the day prior to the last chemotherapy infusion.

Group II: Usual care Active Control 1 Intervention

Contact limited to study assessments.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Breast Cancer Research Foundation

Collaborator

Trials

79

Recruited

40,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11499338/

The effectiveness of exercise and/or nutritional ... The focus of this scoping literature review was to determine the scale of evidence regarding the effectiveness of exercise and/or nutritional interventions for ...

2. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.35043

What are the most effective exercise, physical activity and ... This systematic review and network meta-analysis aimed to identify the most effective exercise, physical activity, and dietary interventions to reduce fat mass ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.00871

Randomized Trial of Exercise and Nutrition on ... The LEANer trial demonstrated that women with breast cancer initiating chemotherapy were able to make significant improvements in exercise and ...

4. nature.com nature.com/articles/s41598-025-11660-0

Implementing exercise and self-management for women ... Low-frequency exercise training improves cardiovascular fitness and strength during treatment for breast cancer: a single-arm intervention study.

5. cardiooncologyjournal.biomedcentral.com cardiooncologyjournal.biomedcentral.com/articles/10.1186/s40959-024-00235-z

Effectiveness of exercise modalities on breast cancer patient ... Overall exercise significantly improves the HRQOL, CRF and physical function in patients with BC. HRQOL was improved with all exercise types.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9964362/

Effects of Combined Interventions of Exercise and Diet or ... The main finding of this systematic review is that groups performing interventions combining exercise plus diet show significant improvements in ...

7. biosignaling.biomedcentral.com biosignaling.biomedcentral.com/articles/10.1186/s12964-024-01634-6

Outcomes of physical exercises on initiation, progression, and ... Evidence has suggested that participation in physical activity is correlated with a decrease in reappearance and fatality rates of breast cancer patients.

8. nature.com nature.com/articles/s41591-024-03143-y

Supervised, structured and individualized exercise in ... Our results indicate that the exercise intervention not only had a positive effect on physical fatigue and HRQOL but also on pain and dyspnea.

9. sciencedirect.com sciencedirect.com/science/article/pii/S1551714421002445

Effect of healthy diet and exercise on chemotherapy ... Higher levels of physical activity and lower body mass index (BMI) have been shown to be associated with better adherence to chemotherapy completion rate and ...