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

• ClinicalTrials.gov Identifier: NCT03779867
• Recruitment Status: Completed
• First Posted: December 19, 2018
• Last Update Posted: July 8, 2022
• Sponsor: Fred Hutchinson Cancer Center
• Collaborator: Breast Cancer Research Foundation
• Information provided by (Responsible Party): Fred Hutchinson Cancer Center

Tracking Information

• First Submitted Date: December 17, 2018
• First Posted Date: December 19, 2018
• Last Update Posted Date: July 8, 2022
• Actual Study Start Date: March 25, 2019
• Actual Primary Completion Date: June 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 17, 2018)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 7, 2020)

• 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.
• 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.
• Change in C-reactive protein (CRP) [ Time Frame: Baseline up to 105 minutes ]
  Will compare changes in CRP level from baseline to 105 minutes between the exercisers and controls.
• Change in Interleukin (IL)-6 [ Time Frame: Baseline up to 105 minutes ]
  Will compare changes in IL-6 level from baseline to 105 minutes between the exercisers and controls.
• Change in Monocyte chemotactic protein (MCP)-1 [ Time Frame: Baseline up to 105 minutes ]
  Will compare changes in MCP-1 level from baseline to 105 minutes between the exercisers and controls.
• Change in Plasminogen activator inhibitor type-1 (PAI-1) [ Time Frame: Baseline up to 105 minutes ]
  Will compare changes in PAI-1 level from baseline to 105 minutes between the exercisers and controls.
• Change in Vascular Endothelial Growth Factor (VEGF) [ Time Frame: Baseline up to 105 minutes ]
  Will compare changes in VEGF level from baseline to 105 minutes between the exercisers and controls.

Original Secondary Outcome Measures (submitted: December 17, 2018)

• 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.
• 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Acute Exercise Intervention in Reducing Breast Cancer Risk in Healthy Participants
• Official Title: Acute Effects of Exercise in Women (ACE) Study
• 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.

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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Breast Carcinoma

Intervention

• Behavioral: Exercise Intervention
  Undergo acute exercise
• Other: Resting
  Seated resting
  Other Name: Rest
• Other: Biomarker Analysis
  Correlative studies
• Other: Questionnaire Administration
  Ancillary studies

Study Arms

• Experimental: Arm I (acute exercise)
  Participants undergo a moderate-intensity acute exercise bout over 45 minutes.
  Interventions:

  • Behavioral: Exercise Intervention
  • Other: Biomarker Analysis
  • Other: Questionnaire Administration
• Active Comparator: Arm II (rest)
  Participants rest by sitting for 45 minutes.
  Interventions:

  • Other: Resting
  • Other: Biomarker Analysis
  • Other: Questionnaire Administration

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 6, 2022): 102
• Original Estimated Enrollment (submitted: December 17, 2018): 100
• Actual Study Completion Date: June 30, 2022
• Actual Primary Completion Date: June 30, 2022 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03779867
• Other Study ID Numbers: RG1003977; NCI-2018-02831 ( Registry Identifier: NCI / CTRP ); 8766 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Fred Hutchinson Cancer Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Fred Hutchinson Cancer Center
• Original Study Sponsor: Same as current
• Collaborators: Breast Cancer Research Foundation

Investigators

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

• PRS Account: Fred Hutchinson Cancer Center
• Verification Date: July 2022