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

112 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how a 45-minute bout of acute exercise in women with a history of breast cancer can affect factors associated with breast cancer and help doctors learn more about how exercise can help prevent breast cancer. In an earlier part of the study, investigators looked at the effects of the same intervention in women without a history of cancer.

Research Team

Anne McTiernan

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

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

All race and ethnic groups are eligible for the study

I finished my main cancer treatment over 6 months ago.

Willing to consent to release of medical records for their breast cancer diagnosis and treatment

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

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)

Treatment Details

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.

Participant Groups

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+