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Acute Exercise Intervention in Breast Cancer Survivors | Clinical Trials | Clareo Health

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Acute Exercise Intervention in Breast Cancer Survivors

Acute Effects of Exercise on Breast Cancer Biomarkers (ACE) Study

NCT03779867•Fred Hutchinson Cancer Center

Summary

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.

Detailed Description

OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants undergo a moderate-intensity acute exercise bout over 45 minutes. ARM II: Participants rest by sitting for 45 minutes. EXTENSION: After completion of initial study recruitment and data collection, an extension was approved in 2023. EXTENSION OUTLINE: Participants are randomized to 1 of 2 arms. EXTENSION ARM I: Participants exercise on a stationary bike for 45 minutes. EXTENSION ARM II: Participants rest by sitting for 45 minutes.

Eligibility

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Female
•History of Stage 0-IIIc breast cancer, diagnosed within the last 5 years
•Completed primary treatment at least 6 months ago
•Able to attend 2 clinic visits at the Fred Hutch Prevention Center for approximately 2.5 hours at a time
•Aged 36-75 years. Younger women will be excluded because a sizable proportion may remain premenopausal and will resume menstruation within 2 years of chemotherapy completion.
•Postmenopausal (no menstrual periods in the previous 12 months either naturally, or as a consequence of treatment)
•All race and ethnic groups are eligible for the study
•Able to perform all study requirements, including attendance at clinic visits and capable of responding to questionnaires and clinic and exercise facility instructions in English
•Willing to consent to release of medical records for their breast cancer diagnosis and treatment
•If a patient has received a cardiotoxic therapy (e.g., Adriamycin, Herceptin), clearance of their oncologist to participated in this study will be required.
+5 more criteria

Exclusion Criteria

•Family history of breast cancer
•If known, BRCA 1/2 mutation carrier
•If known, Li-Fraumeni Syndrome
•Personal history of cancer other than breast: exceptions are non-melanoma skin cancer and cervical neoplasia (CIN)
•Serious health conditions including diabetes, renal disease (e.g., chronic kidney disease), liver disease (e.g., cirrhosis, chronic liver failure), chronic lung disease (COPD, moderate or severe persistent asthma), auto-immune disease requiring oral or inhaled medication, congestive heart failure, or other condition likely to interfere with ability to exercise at moderate levels and undergo biosampling, or likely to interfere with study outcomes.
•Fasting glucose fingerstick \>126 mg/dL
•Taking any medications to treat high blood sugar such as metformin
•Contraindications for exercise testing (29) including: recent (within 6 months) cardiac event (MI, pulmonary edema, myocarditis, pericarditis), unstable angina, uncontrolled arrhythmia, third degree heart block, left bundle branch block, acute congestive failure, recent (within 6 months) pulmonary/systemic embolus, severe electrolyte abnormality, deep vein thrombosis, uncontrolled hypertension (systolic \> 200, diastolic \> 100), orthostatic hypotension, moderate/severe aortic stenosis, uncontrolled arrhythmia, uncontrolled congestive heart failure, history of cardiac arrest or stroke, or as assessed by the physician assistant during the physical exam.
•History of clotting disorders
•Unable or unwilling to stop aspirin or NSAIDs for 48 hours before and after the procedure
+27 more criteria

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Key Dates

Start Date

March 25, 2019

Primary Completion Date

December 31, 2024

Completion Date

December 31, 2024

Last Updated

January 23, 2025

Enrollment

112

ACTUAL participants

Conditions

Breast Carcinoma

Interventions

Exercise Intervention

BEHAVIORAL

Resting

OTHER

Biomarker Analysis

OTHER

Questionnaire Administration

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Acute Exercise Intervention in Breast Cancer Survivors

Inclusion Criteria

Exclusion Criteria

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