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Acute Exercise Intervention in Reducing Breast Cancer Risk in Healthy Participants

Trial Status: Active

This trial studies how well acute exercise intervention works in reducing the risk of breast cancer in healthy participants. Acute exercise intervention may affect factors associated with breast cancer and help doctors learn more about how exercise can help prevent breast cancer.

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)

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE
Contact: Anne McTiernan
Phone: 206-667-7979

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