ACTIVE_NOT_RECRUITING

Lifestyle Intervention for the Reduction of Breast Cancer Risk in Normal Weight Women

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

This trial studies how well a lifestyle intervention works in reducing breast cancer risk through changing body composition and decreasing inflammation in normal weight women. This trial may help researchers learn more about diet and exercise programs designed to decrease body fat in postmenopausal women who are of normal weight but have an elevated risk of breast cancer because of excess body fat.

Official Title

Reducing Breast Cancer Risk Through Modifying Body Composition and Decreasing Inflammation in Normal Weight Women

Quick Facts

Study Start:2020-01-10
Study Completion:2025-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04267796

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:50 Years to 69 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 50-69 years old
  2. * Postmenopausal woman (absence of menstruation for at least one year, or history of bilateral oophorectomy)
  3. * Self-reported height and weight indicating a BMI \>= 18.5 and \< 25 kg/m\^2
  4. * No contraindications to exercise (either no positive responses on the Physical Activity Readiness Questionnaire, or clearance from a health care provider certifying that the participant is healthy enough to exercise)
  5. * No history of invasive cancer, other than non-melanoma skin cancer
  6. * No history of renal disease
  7. * Able to walk without an assistive device
  8. * Not within 3 months of major surgery
  9. * Able to speak/read/write in English
  10. * Has internet access on a computer or mobile device
  11. * A trunk fat mass \>= 9.4 kg as indicated by a dual x-ray absorptiometry (DXA) scan
  12. * Height and weight indicating a BMI of \>= 18.5 and \< 25 kg/m\^2 verified at the screening visit
  1. * MD Anderson employees that report to the principal investigator of this study
  2. * Participants that cannot engage in the exercise program for more than three weeks during the study period
  3. * Participants that are currently doing strength exercises that work all major muscle groups (defined as: participants who complete more than 16 repetitions per exercise in their current resistance training regimen, or who don't find their last 1-2 reps to be difficult in their current regimen, or who increase the weight in their current routine).

Contacts and Locations

Principal Investigator

Karen M Basen-Engquist
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Karen M Basen-Engquist, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

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 Date2020-01-10
Study Completion Date2025-07-01

Study Record Updates

Study Start Date2020-01-10
Study Completion Date2025-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Carcinoma