RPFNA Assessment of Exercise Effect in Breast Cancer

NCT01961128 | Completed

• 1 other identifier: 11-291
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Keywords

High risk

Outcome Measures

Primary Outcomes (1)

• Feasibility of enrolling patients in a study looking at the impact of exercise upon breast tissue markers

  This is a small pilot feasability study designed to see if we can recruit patients into this kind of trial and if we can measure biomarker expression in breast tissue collected through RPFNA. Data analyses will be primarily descriptive in this pilot study. The primary feasibility endpoint will be assessed by the number of women with pre- and post-exercise RPFNA samples with sufficient cells (\> 500) for analysis. We require evidence that at least 60% of participants could provide adequate samples order to declare success in this pilot study. Therefore, if 10 of 12 enrolled women have RPFNA samples at both times with sufficient cells, the lower bound of the one-sided, 90% exact confidence interval will exceed 60% and the study will be considered feasible.

  2 years

Secondary Outcomes (1)

• Secondary objectives will explore changes in proliferative and morphologic indices of the breast as expressed by changes in Ki-67 and the Masood index.

  2 years

Study Arms (1)

Exercise Intervention

EXPERIMENTAL

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

Behavioral: Exercise Intervention

Interventions

Exercise Intervention BEHAVIORAL

Exercise Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jennifer Ligibel, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 4, 2013
• First Posted: October 11, 2013
• Study Start: October 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 29, 2014

Record last verified: 2014-04

Locations

US (1)