Acute Exercise Intervention in Reducing Breast Cancer Risk in Healthy Participants

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: regular menstrual periods for the previous 6 months; no use of oral contraceptives for the previous 3 months, no hormone implants or intrauterine device (IUD) for the previous year, no 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)

PRIMARY OBJECTIVES:

I. Recruit and randomize 100 healthy women into a one‐time 45‐minute acute moderate intensity exercise bout or a 45‐minute resting period (sitting, control group).

II. Obtain strategically timed blood from all participants and muscle biospecimens from a subset of 20 women, before and after exercise (or rest).

III. Test exercise versus (vs.) rest on insulin, glucose, and insulin resistance (homeostatic model assessment of insulin resistance [HOMA‐IR]).

SECONDARY OBJECTIVE:

I. Compare effects of exercise vs. rest on HOMA‐IR in normal‐weight (body mass index [BMI] < 25.0 mg/kg^2) versus overweight/obese (BMI >= 25.0 kg/m^2) study participants.

EXPLORATORY OBJECTIVE:

I. In a subset of 20 women, test exercise vs. rest effects on muscle- and adipose-tissue specific abundance and activation states of key signaling proteins, using a high throughput lysate microarraying and fluorescence-based quantitative immunoblotting technology.

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.

Trial Phase Phase NA

Trial Type Prevention

Lead Organization
Fred Hutch / University of Washington Cancer Consortium

Principal Investigator
Anne McTiernan

• Primary ID RG1003977
• Secondary IDs NCI-2018-02831, ACE
• Clinicaltrials.gov ID NCT03779867