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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~12-weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-weeks for reporting.

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 more

Trial 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

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,586 Total Patients Enrolled
938 Trials studying Breast Cancer
1,543,273 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteLead Sponsor
1,072 Previous Clinical Trials
340,346 Total Patients Enrolled
140 Trials studying Breast Cancer
22,511 Patients Enrolled for Breast Cancer
Jennifer Ligibel, MDPrincipal InvestigatorDana-Farber Cancer Institute
8 Previous Clinical Trials
3,860 Total Patients Enrolled
6 Trials studying Breast Cancer
623 Patients Enrolled for Breast Cancer

Media Library

Exercise Intervention Clinical Trial Eligibility Overview. Trial Name: NCT03657628 — N/A
Breast Cancer Research Study Groups: Physical activity
Breast Cancer Clinical Trial 2023: Exercise Intervention Highlights & Side Effects. Trial Name: NCT03657628 — N/A
Exercise Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03657628 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does your research initiative include individuals aged 40 and older?

"As per the inclusion criteria, this trial is open to patients aged between 18 and 50. For individuals below 18 years old, 74 clinical trials are available while those above 65 can choose from 2508 different medical studies."

Answered by AI

Are researchers currently accepting new participants for this clinical trial?

"According to the clinicaltrials.gov information, this trial is not currently recruiting participants and has been inactive since January 5th 2022. Nonetheless, there are a plethora of other trials actively accepting candidates at present - 2603 in total."

Answered by AI

What are the criteria for participating in this research study?

"This clinical trial has the capacity to recruit sixty women aged 18 and 50 with a history of breast cancer. Eligibility requirements include having undergone hysterectomy without oophorectomy, providing written informed consent before any procedures related to the study, regular menstrual cycles, an intact IUD, heterogeneously dense or very dense (BIRADS 3 or 4) breast tissue on mammogram within three years, physical inactivity consisting of less than ninety minutes of moderate or vigorous intensity PA per week , no prior history of breast cancer , being at least eighteen years old , physically capable of exercising , English speaking and literate."

Answered by AI
~4 spots leftby Aug 2024