Clinicaltrials.gov identifier:
NCT02494869
Study Contact Information:
New York, NY
Memorial Sloan Kettering Cancer Center
Contact: Lee Jones, PhD by phone: 646-888-4698 or Neil Iyengar, MD by phone: 646-888-4714
Dose-Response of Aerobic Training in Post-Menopausal Women at High-Risk for Development of Breast Cancer
NOTE: This study enrollment has closed.
About the Study
This study will look at the effect that different amounts of exercise training has on risk factors in post-menopausal women at high risk for breast cancer. These risk factors include exercise capacity, body weight, and body composition, as well as the expression of certain genes and levels of inflammatory factors in your breast tissue. Visit the study website for more information.
Type of Study
This is a , four arm study. The study period will last six months.
- The study has four arms. This means that patients in the study are placed in one of four different groups. Patients in three of the groups will be asked to exercise over a six month period. One group of patients will be asked not to exercise during the study period.
- This is a study, which means that participants will be placed into one of the four groups by chance. Neither patients nor the research doctor will choose the group participants are placed in.
What the Study Entails
- At the beginning of the study, women will need to have a needle biopsy of breast tissue for analysis, as well as body composition assessment, blood tests, and other tests.
- After the needle biopsy and other tests, women will be assigned to one of four groups, and will be asked to do the following over the six month study period:
- Group 1 will be asked to walk on a treadmill three times a week for a total of 75 minutes.
- Group 2 will be asked to walk on a treadmill three times a week for a total of 150 minutes.
- Group 3 will be asked to walk on a treadmill five times a week for a total of 300 minutes
- Group 4 will be asked to do no exercise during the study period (but these women will be “wait-listed” to start 150 minutes of weekly exercise training after the study period)
- At the end of the six-month study period, all women in the study will have a breast needle biopsy and the other tests they had at the beginning of the study repeated, and the results of the two sets of tests will be compared to evaluate the effects of exercise.
Background
Prior studies have shown that high levels of exercise may reduce breast cancer risk, but what has not been known is the best intensity and amount of exercise required to be protective. Nor is it known how exercise reduces breast cancer risk. In this study, researchers want to determine the optimal amount of exercise needed to change certain factors associated with breast cancer risk.
Study Lead Investigator
Principal Investigator: Lee Jones, PhD
Contact information: Phone: 646-888-4698
THIS STUDY ENROLLMENT HAS CLOSED