Breast Cancer Clinical Trial

Acute Exercise Intervention in Reducing Breast Cancer Risk in Healthy Participants

Summary

This trial studies how well a bout of acute exercise in healthy participants can help reduce risk of breast cancer in healthy participants. An acute exercise intervention may affect factors associated with breast cancer and help doctors learn more about how exercise can help prevent breast cancer.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Resident in greater Seattle metropolitan area (King County), Pierce or Snohomish Counties
Healthy
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 be randomized
Capable of providing informed consent

Exclusion Criteria:

Pregnant in past 3 months
Lactating
Premenopausal women: irregular menstrual periods for the previous 6 months; no use of oral contraceptives for the previous 3 months, no use of hormone implants or intrauterine device (IUD) for in the previous year, no use of other sex hormones including testosterone or other androgens for the previous 3 months
Postmenopausal women: no use of any sex hormones (estrogen, progesterone, testosterone or other androgens, for the previous 3 months) of any type including oral, creams, vaginal creams or inserts, patches, implants
Current use of any tobacco products including smoking, vaping, chew, nicotine patches
History of diabetes mellitus, or fasting glucose fingerstick ≥ 126 mg/dL
Taking any medications to treat high blood sugar such as metformin
Personal history of invasive or in situ breast cancer
Personal history of cancer other than breast: exceptions are non-melanoma skin cancer and cervical neoplasia (CIN)
≥ 2 alcoholic drinks/day
Contraindications to exercise
Abnormalities on screening physical that contraindicate participation
Contraindications for entry into a research exercise program: recent (within 6 months) myocardial infarction, pulmonary edema, myocarditis, pericarditis, unstable angina, pulmonary embolism, deep vein thrombosis, uncontrolled hypertension (systolic > 200, diastolic > 100), orthostatic hypotension, moderate/severe aortic stenosis, uncontrolled arrhythmia, uncontrolled congestive heart failure, left bundle branch block, history of cardiac arrest or stroke
Frequent marijuana use (> 1 per month)
Alcohol or drug abuse, significant mental illness (as assessed by study staff impression)
History of clotting disorders (muscle-biopsy sub study)
Unable or unwilling to stop aspirin or nonsteroidal antiinflammatory drugs (NSAIDs) for 48 hours before and after the procedure (muscle-biopsy sub study)
Allergy to anesthetics or local anesthetics (muscle-biopsy sub study)
Long term use of warfarin or similar medications (muscle-biopsy sub study)

Study is for people with:

Breast Cancer

Estimated Enrollment:

102

Study ID:

NCT03779867

Recruitment Status:

Completed

Sponsor:

Fred Hutchinson Cancer Center

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There is 1 Location for this study

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Fred Hutch/University of Washington Cancer Consortium
Seattle Washington, 98109, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

102

Study ID:

NCT03779867

Recruitment Status:

Completed

Sponsor:


Fred Hutchinson Cancer Center

How clear is this clinincal trial information?

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