Acute Exercise Intervention in Reducing Breast Cancer Risk in Healthy Participants
- Resident in greater Seattle metropolitan area (King County), Pierce or Snohomish Counties
- 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
- Pregnant in past 3 months
- 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)
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]).
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.
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
Fred Hutch / University of Washington Cancer Consortium
- Primary ID RG1003977
- Secondary IDs NCI-2018-02831, ACE
- Clinicaltrials.gov ID NCT03779867