RPFNA Assessment of Exercise Effect in Breast Cancer

NCT ID: NCT01961128

Last Updated: 2014-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-03-31

Brief Summary

This study is being done to see if the investigators can measure changes that occur in breast tissue when women at risk of developing breast cancer start an exercise program. The investigators are interested in studying this because research shows that women who exercise regularly are less likely to develop breast cancer, but there is not very much information explaining how exercise could affect breast cells in a way to prevent cancer from occurring. In this research study the investigators will use a research technique called breast random fine needle aspiration (RPFNA) to test breast cells for their shape and how they look. The investigators will look at breast cells before and after a participant takes part in an exercise program to see if the investigators are able to see any changes in breast cells that could have happened due to the exercise program. This research will help us to develop larger projects to see if exercise programs could be helpful in preventing breast cancer.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Exercise Intervention

220 minutes of exercise per week, including 2-3 supervised sessions for 6 weeks

Group Type: EXPERIMENTAL

Exercise Intervention

Intervention Type: BEHAVIORAL

Interventions

Exercise Intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• History of lobular carcinoma in situ, atypical ductal/lobular hyperplasia on prior breast biopsy or lifetime risk of breast cancer of at least 20% based on any risk model, or personal history of BRCA1 or 2 mutation
• Physically able to exercise and physician consent to start an exercise program
• Sedentary activity pattern
• Premenopausal
• English speaking and able to read English

Exclusion Criteria

• History of invasive breast cancer or ductal carcinoma in situ
• Absolute contraindications to maximal exercise testing as recommended by the American Thoracic Society
• Any condition which in the investigator's opinion makes the subject unsuitable for study participation
• Participating in another clinical study with competing study outcomes
• Pregnant or breastfeeding
• Unable to comply with protocol and/or not available for follow-ups
• Type II Diabetes
• Allergic to local anesthetics
• History of bilateral or unilateral mastectomy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Jennifer A. Ligibel, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Ligibel, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

11-291

Identifier Type: -

Identifier Source: org_study_id