RECRUITING

Resistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D)

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Conditions

Breast CancerBreast Cancer FemaleBreast Cancer RiskDense breast tissueDense breasts

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to learn more about how exercise might lower the risk of developing breast cancer in women with dense breast tissue by studying changes that occur in breast tissue and blood as a result of participating in an exercise program. The names of the study groups in this study are: * Exercise Training Group * Waitlist Control Group

Official Title

Resistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D)

Quick Facts

Study Start:2024-03-28
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06322888

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 59 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women aged 18-59
  2. * Heterogeneously dense/extremely dense (BIRADS 3 or 4) breast tissue on mammogram within the past 12 months
  3. * Physically inactive; engaging in \<60 minutes of moderate or vigorous intensity exercise per week, as assessed by Godin Leisure Time screener
  4. * Not pregnant or breastfeeding
  5. * English speaking and able to read English. Investigators are only enrolling English-speaking participants to this study at this time due to the fact that investigators currently only have English-speaking exercise trainers with the proper qualifications to conduct the exercise training
  6. * Written informed consent prior to any study-related procedures
  1. * Self-reported inability to walk 2 blocks (at any pace)
  2. * Prior history of breast cancer; prior DCIS is allowable as long as participant is not taking endocrine therapy and has at least 1 breast that has not been irradiated
  3. * On oral or implantable hormonal contraceptives, postmenopausal hormone replacement therapy, a selective estrogen receptor modulator or an aromatase inhibitor; Mirena or other IUD is acceptable
  4. * Consistent strength training in the past 3 months
  5. * Use of weightloss drugs
  6. * Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate exercise. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility
  7. * Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder)

Contacts and Locations

Study Contact

Jennifer Ligibel, MD
CONTACT
617-632-3800
jennifer_ligibel@dfci.harvard.edu
Anna Tanasijevic, MPH
CONTACT
617-632-5584
anna_tanasijevic@dfci.harvard.edu

Principal Investigator

Jennifer Ligibel, MD
PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

  • Jennifer Ligibel, MD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-28
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-03-28
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Breast Cancer
  • Breast Cancer Female
  • Breast Cancer Risk
  • Dense breast tissue
  • Dense breasts

Additional Relevant MeSH Terms

  • Breast Cancer
  • Breast Cancer Female