Exercise for Reducing Breast Cancer Risk

(ACE Trial)

Overseen By Catherine Duggan

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Research Center

Must be taking: Anti-estrogen therapy

Must not be taking: Diabetic drugs, Sex hormones

Disqualifiers: Diabetes, Heart disease, Cancer, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a single 45-minute session of moderate exercise (Exercise Intervention) affects factors related to breast cancer. The goal is to determine if exercise can help prevent breast cancer in women with a history of the disease. Participants will either engage in the exercise or rest for the same duration to compare results. Women diagnosed with Stage 0-IIIc breast cancer in the last five years who completed their primary treatment at least six months ago may be suitable candidates. As an unphased trial, this study allows participants to contribute to groundbreaking research on exercise and breast cancer prevention.

Will I have to stop taking my current medications?

You may need to stop certain medications, like aspirin, NSAIDs, and some others that affect exercise or blood markers, for a short time around the study procedures. However, you can continue maintenance anti-estrogen therapy like tamoxifen or aromatase inhibitors.

What prior data suggests that this exercise intervention is safe for women with a history of breast cancer?

Research has shown that exercise is generally safe for individuals who have had breast cancer. Studies have found that physical activity can improve their quality of life. For instance, one study discovered that exercise did not worsen lymphedema—a condition that causes swelling—but instead helped manage fluid balance.

Additionally, exercise has been linked to a lower chance of breast cancer recurrence and reduced death rates from the disease. This suggests it is not only safe but also potentially beneficial.

Previous research on women without a history of cancer has found similar exercise routines to be safe. Therefore, participating in a trial like this likely involves low risk and could provide valuable insights into preventing breast cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the exercise intervention for reducing breast cancer risk because it offers a non-invasive and natural approach to prevention. Unlike traditional options that might involve medication or surgery, this method focuses on using moderate-intensity exercise to potentially lower risk factors associated with breast cancer. The uniqueness lies in its simplicity and accessibility—exercise is something most people can incorporate into their daily lives without the need for medical procedures or prescriptions. Additionally, this approach could provide a holistic benefit, improving overall health and well-being while targeting cancer risk reduction.

What evidence suggests that exercise might be an effective treatment for reducing breast cancer risk?

This trial will compare the effects of an exercise intervention with a rest period. Research has shown that exercise benefits individuals who have had breast cancer. One study found a link between physical activity and reduced cancer recurrence, as well as increased longevity. Another study demonstrated that strength exercises help breast cancer patients build muscle, which is crucial for recovery and maintaining health. Exercise also enhances the quality of life for breast cancer survivors by alleviating disease-related symptoms. Overall, exercise is considered a valuable addition to treatment, supporting both physical and mental health for those with breast cancer. ^{2 4 6 7 8}

Who Is on the Research Team?

Anne McTiernan

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for women aged 36-75, postmenopausal, who are healthy or have had Stage 0-IIIc breast cancer within the last 5 years and finished treatment at least 6 months ago. Participants must live in the greater Seattle area, be able to attend clinic visits, understand English instructions and questionnaires, and provide consent. Exclusions include certain genetic syndromes like Li-Fraumeni Syndrome, diabetes, heavy alcohol use (>2 drinks/day), tobacco use, drug abuse or significant mental illness.

Inclusion Criteria

I have not had a menstrual period in the last 12 months.

I understand the study and can agree to participate.

All race and ethnic groups are eligible for the study

Exclusion Criteria

History of clotting disorders (muscle-biopsy sub study)

I have a family history of breast cancer.

I carry a BRCA 1 or BRCA 2 gene mutation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo a 45-minute bout of moderate-intensity acute exercise or rest

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in biomarkers up to 105 minutes after intervention

105 minutes

Extension

Participants may opt into an extension phase involving exercise or rest for 45 minutes

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Intervention

Trial Overview The study examines how a single session of acute exercise affects factors related to breast cancer risk in both healthy participants and breast cancer survivors. It involves resting periods as well as exercise intervention followed by biomarker analysis and questionnaire administration.

How Is the Trial Designed?

Group I: Arm I (acute exercise) Experimental Treatment 3 Interventions

Participants undergo a moderate-intensity acute exercise bout over 45 minutes.

Group II: Arm II (rest) Active Control 3 Interventions

Participants rest by sitting for 45 minutes.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Research Center

Lead Sponsor

Trials

444

Recruited

148,000+

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

Breast Cancer Research Foundation

Collaborator

Trials

79

Recruited

40,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9873715/

Long-term effects of exercise interventions on physical ... The physical activity behaviour in breast cancer patients remained improved for several months beyond the end of exercise interventions, but effects were small.

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

What are the most effective exercise, physical activity and ... Resistance exercise was the most effective intervention to increase lean mass (0.7 kg; 95% CI, 0.5–1.0 kg) in breast cancer patients.

3. 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.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0748798325007152

Effect of physical exercise on the quality of life of women ... Women surviving breast cancer (WSBC) may experience reduced quality of life (QoL) due to disease-associated manifestations and undergone treatment. Engagement ...

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

Implementing exercise and self-management for women ... Multiple studies demonstrate that exercise is a beneficial adjunctive treatment for individuals with BC, positively impacting both physical and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5981588/

Physical Activity, Exercise and Breast Cancer Therefore, the aim of this article was to review the current data from which exercise recommendations are generated and discuss targeted exercise programs and ...

7. cancer.gov cancer.gov/about-cancer/causes-prevention/risk/obesity/physical-activity-fact-sheet

Physical Activity and Cancer Fact Sheet - NCI A fact sheet that summarizes evidence linking physical activity (including exercise) to reduced cancer risk and sedentary behavior ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835176

Resistance Training and Lymphedema in Breast Cancer ... In this cohort study of breast cancer survivors, intense resistance training did not exacerbate lymphedema and was associated with improvements in fluid ...