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NCT Number: NCT01961128

RPFNA Assessment of Exercise Effect in Breast Cancer

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise Intervention

Behavioral

Primary outcomes

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

    Time frame: 2 years

    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 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.

    Time frame: 2 years

    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.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

Pilot Feasibility Study of the Use of Random Periareolar Fine Needle Aspiration Exercise Induced Changes in Breast Tissue

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 11, 2013
Registry last updated
Apr 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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