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Exercise for Reducing Breast Cancer Risk (ACE Trial)
N/A
Recruiting
Led By Anne McTiernan
Research Sponsored by Fred Hutchinson Cancer Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 105 minutes
Awards & highlights
ACE Trial Summary
This trial studies how 45 minutes of exercise can help prevent breast cancer in healthy and breast cancer survivors.
Who is the study for?
This trial is for women aged 36-75, postmenopausal, who are healthy or have had Stage 0-IIIc breast cancer within the last 5 years and finished treatment at least 6 months ago. Participants must live in the greater Seattle area, be able to attend clinic visits, understand English instructions and questionnaires, and provide consent. Exclusions include certain genetic syndromes like Li-Fraumeni Syndrome, diabetes, heavy alcohol use (>2 drinks/day), tobacco use, drug abuse or significant mental illness.Check my eligibility
What is being tested?
The study examines how a single session of acute exercise affects factors related to breast cancer risk in both healthy participants and breast cancer survivors. It involves resting periods as well as exercise intervention followed by biomarker analysis and questionnaire administration.See study design
What are the potential side effects?
Since this trial involves an acute exercise intervention rather than medication or invasive procedures, side effects may include typical responses to physical activity such as muscle soreness or fatigue.
ACE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 105 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 105 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Irisin level
Change in PAI-1 level
Change in Plasminogen activator inhibitor type-1 (PAI-1) level
+6 moreSecondary outcome measures
Change in C-reactive protein (CRP)
Change in Interleukin (IL)-6
Change in Monocyte chemotactic protein (MCP)-1
+2 moreACE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (acute exercise)Experimental Treatment3 Interventions
Participants undergo a moderate-intensity acute exercise bout over 45 minutes.
Group II: Arm II (rest)Active Control3 Interventions
Participants rest by sitting for 45 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise Intervention
2016
Completed Phase 4
~1330
Find a Location
Who is running the clinical trial?
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,230 Total Patients Enrolled
15 Trials studying Breast Cancer
19,018 Patients Enrolled for Breast Cancer
Fred Hutchinson Cancer CenterLead Sponsor
557 Previous Clinical Trials
1,343,373 Total Patients Enrolled
18 Trials studying Breast Cancer
21,498 Patients Enrolled for Breast Cancer
Breast Cancer Research FoundationOTHER
69 Previous Clinical Trials
137,625 Total Patients Enrolled
42 Trials studying Breast Cancer
130,477 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a family history of breast cancer.I carry a BRCA 1 or BRCA 2 gene mutation.I have Li-Fraumeni Syndrome.I have had cancer before, but it was only non-melanoma skin cancer or cervical neoplasia.I do not have serious health conditions that would affect my participation.I have diabetes or my blood sugar level is high.I am a postmenopausal woman and haven't used any sex hormones for the last 3 months.I cannot or will not stop taking aspirin or NSAIDs for 2 days before and after a procedure.I have been using warfarin or similar blood thinners for a long time.I have not had a recent severe heart or blood vessel problem.I have a history of blood clotting disorders.I am not taking medications that could affect my exercise ability or certain blood and muscle tests.I cannot or will not stop taking aspirin or NSAIDs for 2 days before and after a muscle biopsy.I finished my main cancer treatment over 6 months ago.I have not had a menstrual period in the last 12 months.I understand the study and can agree to participate.I have been on warfarin or similar blood thinners for a long time.I haven't had recent severe heart or blood pressure issues.I am female.I was diagnosed with Stage 0-IIIc breast cancer in the last 5 years.I have had breast cancer before.I can go to 2 clinic visits at Fred Hutch for about 2.5 hours each.My oncologist has approved my participation in this study despite my previous heart-affecting cancer treatments.I currently use tobacco products.I am taking medication for high blood sugar, like metformin.I am between 36 and 75 years old.I have not used any sex hormones except for maintenance anti-estrogen therapy like tamoxifen in the last 3 months.I am a premenopausal woman with irregular periods and haven't used hormonal contraceptives or therapies recently.I have no physical conditions that prevent me from joining.I can attend all clinic visits, follow instructions, and answer questionnaires in English.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (acute exercise)
- Group 2: Arm II (rest)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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