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ACE: Acute Exercise Intervention in Reducing Breast Cancer Risk in Healthy Participants

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT03779867
Collaborator
Breast Cancer Research Foundation (Other)
102
Enrollment
1
Location
2
Arms
39.2
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: Exercise Intervention
  • Other: Resting
  • Other: Biomarker Analysis
  • Other: Questionnaire Administration
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
102 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 :
Mar 25, 2019
Actual Primary Completion Date :
Jun 30, 2022
Actual Study Completion Date :
Jun 30, 2022

Arms and Interventions

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 Names:
  • Rest

    • Other: Biomarker Analysis
    Correlative studies

    Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Mean change in homeostatic model assessment of insulin resistance (HOMA-IR) [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 [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 [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 [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 [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 [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 [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 [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.

    3. Change in C-reactive protein (CRP) [Baseline up to 105 minutes]

      Will compare changes in CRP level from baseline to 105 minutes between the exercisers and controls.

    4. Change in Interleukin (IL)-6 [Baseline up to 105 minutes]

      Will compare changes in IL-6 level from baseline to 105 minutes between the exercisers and controls.

    5. Change in Monocyte chemotactic protein (MCP)-1 [Baseline up to 105 minutes]

      Will compare changes in MCP-1 level from baseline to 105 minutes between the exercisers and controls.

    6. Change in Plasminogen activator inhibitor type-1 (PAI-1) [Baseline up to 105 minutes]

      Will compare changes in PAI-1 level from baseline to 105 minutes between the exercisers and controls.

    7. Change in Vascular Endothelial Growth Factor (VEGF) [Baseline up to 105 minutes]

      Will compare changes in VEGF level from baseline to 105 minutes between the exercisers and controls.

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fred Hutch/University of Washington Cancer Consortium Seattle Washington United States 98109

    Sponsors and Collaborators

    • Fred Hutchinson Cancer Center
    • Breast Cancer Research Foundation

    Investigators

    • Principal Investigator: Anne McTiernan, Fred Hutch/University of Washington Cancer Consortium

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fred Hutchinson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT03779867
    Other Study ID Numbers:
    • RG1003977
    • NCI-2018-02831
    • 8766
    First Posted:
    Dec 19, 2018
    Last Update Posted:
    Jul 8, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Jul 8, 2022