Acute Exercise Intervention in Reducing Breast Cancer Risk in Healthy Participants
Status: | Recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 4/6/2019 |
Start Date: | March 25, 2019 |
End Date: | July 1, 2019 |
Contact: | Anne McTiernan |
Email: | cduggan@fredhutch.org |
Phone: | 206-667-7979 |
ACute Effects of Exercise in Women (ACE) Study
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.
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.
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.
ARM I: Participants undergo a moderate‐intensity acute exercise bout over 45 minutes.
ARM II: Participants rest by sitting for 45 minutes.
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)
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