Women In Steady Exercise Research (WISER) Sister: study design and methods.

Kathryn H Schmitz, Nancy I Williams, Despina Kontos, Mindy S Kurzer, Mitchell Schnall, Susan Domchek, Jill Stopfer, Mary Lou Galantino, Wei-Ting Hwang, Knashawn Morales, Shandong Wu, Laura DiGiovanni, Domenick Salvatore, Desire' Fenderson, Jerene Good, Kathleen Sturgeon, Lorita Grant, Cathy J Bryan, Jess Adelman

Journal: Contemporary clinical trials 2015;41():17-30

PMID: 25559914

Full Text on Elsevier Science View on PubMed

Abstract

PURPOSE

Women at elevated risk for breast cancer are motivated to reduce their risk. Current approaches rely primarily on hormonal intervention. A preventive exercise intervention might address the same hormonal issues, yet have fewer serious side effects and less negative impact on quality of life as compared to prophylactic mastectomy. WISER Sister was a randomized controlled trial which examined effects of two doses of exercise training on endogenous sex hormone exposure, hormonally active breast tissue, and other breast cancer risk factors.

METHODS

Subjects for this single site trial were recruited from across the U.S., in collaboration with organizations that serve women at elevated risk, via emails, flyers, and letters. Eligibility criteria included age ≥ 18, eumenorrheic, and at elevated risk for breast cancer (e.g. BRCA1 or BRCA2 mutation and/or ≥ 18% lifetime risk according to prediction models). A 1:1:1 randomization scheme was used to allocate participants into: control, low dose (150 min/week), or high dose (300 min/week) home based treadmill exercise. Participants provided first morning urine samples daily for two menstrual cycles at study beginning and end for calculation of endogenous hormone exposure. In addition, women completed breast dynamic contrast enhanced magnetic resonance imaging, a fasting blood draw, a treadmill exercise test, and surveys at baseline and follow-up.

DISCUSSION

WISER Sister randomized 139 women, 122 of whom completed the study. The overall drop-out rate was 12%. Findings will be useful in understanding the potential for exercise to assist with reducing risk for breast cancer among women at elevated risk.

Address: Department of Biostatistics and Epidemiology, University of Pennsylvania, 8th floor Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104-6021, USA. Electronic address: [email protected].; Department of Kinesiology, The Penn State University, 276 Recreation Building, University Park, PA 16802, USA.; Department of Radiology, University of Pennsylvania, 3400 Spruce St, Philadelphia, PA 19104, USA.; Department of Food Science and Nutrition, 225 FScN, 1334 Eckles Ave, University of Minnesota, St. Paul, MN 55108, USA.; Department of Medicine, Division of Medical Oncology, University of Pennsylvania, 3400 Spruce Street, Philadelphia, PA 19104, USA.; Department of Physical Therapy, Richard Stockton College of New Jersey, 101 Vera King Farris Drive, Galloway, NJ 08205-9441, USA.; Department of Biostatistics and Epidemiology, University of Pennsylvania, 8th floor Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104-6021, USA.; Department of Radiology, University of Pittsburgh, 3352 5th Ave, Room 130, Pittsburgh, PA 15213, USA.

DOI: 10.1016/j.cct.2014.12.016

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MeSH Terms: Adiponectin, Adult, Breast, Breast Neoplasms, Estrone, Exercise Therapy, Female, Genes, BRCA1, Genes, BRCA2, Genetic Predisposition to Disease, Heterozygote, Humans, Leptin, Magnetic Resonance Imaging, Mutation, Pregnanediol, Risk Reduction Behavior, Treatment Outcome