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Acute Exercise Intervention in Reducing Breast Cancer Risk in Healthy Participants (ACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03779867
Recruitment Status : Suspended (COVID19 Suspension)
First Posted : December 19, 2018
Last Update Posted : May 1, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Subject Breast Cancer Female Behavioral: Exercise Intervention Other: Resting Other: Biomarker Analysis Other: Questionnaire Administration Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: All study personnel other than the statisticians and exercise physiologist will be masked to participant study arm
Primary Purpose: Prevention
Official Title: Acute Effects of Exercise in Women (ACE) Study
Actual Study Start Date : March 25, 2019
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm I (acute exercise)
Participants undergo a moderate‐intensity acute exercise bout over 45 minutes.
Behavioral: Exercise Intervention
Undergo acute exercise

Other: Biomarker Analysis
Correlative studies

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Arm II (rest)
Participants rest by sitting for 45 minutes.
Other: Resting
Seated resting
Other Name: Rest

Other: Biomarker Analysis
Correlative studies

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Mean change in homeostatic model assessment of insulin resistance (HOMA‐IR) [ Time Frame: Baseline up to 45 minutes ]
    Will compare the average changes in HOMA‐IR from baseline to 45 minutes between the exercisers and controls.

  2. Mean change in HOMA‐IR [ Time Frame: Baseline up to 105 minutes ]
    Will compare the average changes in HOMA‐IR from baseline to 105 minutes between the exercisers and controls.

  3. Change in insulin level [ Time Frame: Baseline up to 45 minutes ]
    Will compare changes in insulin level from baseline to 45 minutes between the exercisers and controls.

  4. Change in insulin level [ Time Frame: Baseline up to 105 minutes ]
    Will compare changes in insulin level from baseline to 105 minutes between the exercisers and controls.

  5. Change in glucose level [ Time Frame: Baseline up to 45 minutes ]
    Will compare changes in glucose level from baseline to 45 minutes between the exercisers and controls.

  6. Change in glucose level [ Time Frame: Baseline up to 105 minutes ]
    Will compare changes in glucose level from baseline to 105 minutes between the exercisers and controls.


Secondary Outcome Measures :
  1. Effects of exercise on HOMA‐IR in normal‐weight participants [ Time Frame: At 45 minutes ]
    Will use the generalized estimating equations (GEE) model including the potential effect modification of weight category (normal weight versus [vs] overweight/obese) to compare the 45‐minute exercise session on HOMA‐IR in normal‐weight versus overweight/obese women.

  2. Effects of exercise on HOMA‐IR in overweight/obese participants [ Time Frame: At 45 minutes ]
    Will use the GEE model including the potential effect modification of weight category (normal weight versus [vs.] overweight/obese) to compare the 45‐minute exercise session on HOMA‐IR in normal‐weight versus overweight/obese women.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779867


Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Anne McTiernan Fred Hutch/University of Washington Cancer Consortium
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Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT03779867    
Other Study ID Numbers: RG1003977
NCI-2018-02831 ( Registry Identifier: NCI / CTRP )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases