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Exercise Intervention for Dense Breast Tissue
N/A
Waitlist Available
Led By Jennifer Ligibel, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Premenopausal women with regular menstrual cycles
Premenopausal women with a history of hysterectomy without oophorectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-weeks
Awards & highlights
Study Summary
This trial is testing if exercise can lower dense breast tissue markers in premenopausal women.
Who is the study for?
This trial is for premenopausal women under 50 with dense breast tissue who don't exercise much (less than 90 minutes of moderate activity per week). They must be able to read English, have no history of breast cancer, and can walk at least two blocks. Women on oral contraceptives or with certain diseases that limit exercise are not eligible.Check my eligibility
What is being tested?
The study looks at how regular exercise affects markers in the blood and breast tissue related to health. Participants will engage in an exercise intervention designed to see if physical activity can influence factors associated with breast cancer risk.See study design
What are the potential side effects?
Since this trial involves an exercise program, potential side effects may include typical risks associated with physical activity such as muscle soreness, fatigue, or injury. However, these are generally mild and manageable.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a premenopausal woman with regular periods.
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I am a premenopausal woman who has had a hysterectomy but still have my ovaries.
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I have never had breast cancer before.
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I am a woman under 50, premenopausal, and have an intact IUD.
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I can speak and read English.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Impact of exercise upon expression of Ki-67
Secondary outcome measures
Changes in biomarker (CRP)
Changes in biomarker (IL-6)
Changes in biomarker (TNF-a)
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Physical activityExperimental Treatment1 Intervention
The exercise intervention will consist of a supervised, moderate-intensity aerobic exercise program.
Will receive social/behavioral support
Will receive research staff contact time to encourage them to increase their physical activity level
The participants will be given the option of a third supervised session each week
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Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,303 Total Patients Enrolled
941 Trials studying Breast Cancer
1,543,906 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteLead Sponsor
1,080 Previous Clinical Trials
340,870 Total Patients Enrolled
141 Trials studying Breast Cancer
22,560 Patients Enrolled for Breast Cancer
Jennifer Ligibel, MDPrincipal InvestigatorDana-Farber Cancer Institute
9 Previous Clinical Trials
3,906 Total Patients Enrolled
7 Trials studying Breast Cancer
669 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot walk 2 blocks without assistance.I am a premenopausal woman with regular periods.I am a premenopausal woman who has had a hysterectomy but still have my ovaries.I have never had breast cancer before.I had breast cancer or DCIS before, but I'm not on hormone therapy and have one breast not treated with radiation.I do not have heart, lung, or joint problems that stop me from doing moderate exercise.You have a mental health condition, like severe depression, substance abuse, or severe personality disorder, that would make it hard for you to take part in the study.You do not exercise regularly, doing less than 90 minutes of moderate or vigorous physical activity per week.I am a woman under 50, premenopausal, and have an intact IUD.You are able to do physical activities.I can speak and read English.Your recent mammogram shows dense or very dense breast tissue.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Physical activity
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.
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