Back to resultsRPFNA Assessment of Exercise Effect in Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring High risk
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
Sites / Locations
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise Intervention
Arm Description
220 minutes of exercise per week, including 2-3 supervised sessions for 6 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Secondary objectives will explore changes in proliferative and morphologic indices of the breast as expressed by changes in Ki-67 and the Masood index.
Baseline values of percent Ki-67 and Masood index will be summarized using descriptive statistics. The proportions of women with 6-week changes in Masood index of 0 points, 1-2 points, and 3 or more points will be summarized, as will changes in Ki-67 percent. Comparable analyses will be conducted to estimate the changes in concentrations of serum metabolic and inflammatory biomarkers: insulin, glucose, IGF-1, IGFBPs, IL-2, IL-6, CRP, and TNFα. We will also summarize changes in expression of metabolic, sex steroid and related receptors in epithelial breast tissue.
Full Information
NCT ID
NCT01961128
First Posted
January 4, 2013
Last Updated
April 28, 2014
Sponsor
Dana-Farber Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT01961128
Brief Title
RPFNA Assessment of Exercise Effect in Breast Cancer
Official Title
Pilot Feasibility Study of the Use of Random Periareolar Fine Needle Aspiration Exercise Induced Changes in Breast Tissue
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
High risk
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise Intervention
Arm Type
Experimental
Arm Description
220 minutes of exercise per week, including 2-3 supervised sessions for 6 weeks
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Primary Outcome Measure Information:
Title
Feasibility of enrolling patients in a study looking at the impact of exercise upon breast tissue markers
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Secondary objectives will explore changes in proliferative and morphologic indices of the breast as expressed by changes in Ki-67 and the Masood index.
Description
Baseline values of percent Ki-67 and Masood index will be summarized using descriptive statistics. The proportions of women with 6-week changes in Masood index of 0 points, 1-2 points, and 3 or more points will be summarized, as will changes in Ki-67 percent. Comparable analyses will be conducted to estimate the changes in concentrations of serum metabolic and inflammatory biomarkers: insulin, glucose, IGF-1, IGFBPs, IL-2, IL-6, CRP, and TNFα. We will also summarize changes in expression of metabolic, sex steroid and related receptors in epithelial breast tissue.
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Ligibel, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
RPFNA Assessment of Exercise Effect in Breast Cancer
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