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Rationale and design of the Exercise Intensity Trial (EXCITE): A randomized trial comparing the effects of moderate versus moderate to high-intensity aerobic training in women with operable breast cancer.

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Date
2010-10-06
Authors
Jones, Lee W
Douglas, Pamela S
Eves, Neil D
Marcom, P Kelly
Kraus, William E
Herndon, James E
Inman, Brant A
Allen, Jason D
Peppercorn, Jeffrey
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(9 total)
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Abstract
BACKGROUND: The Exercise Intensity Trial (EXcITe) is a randomized trial to compare the efficacy of supervised moderate-intensity aerobic training to moderate to high-intensity aerobic training, relative to attention control, on aerobic capacity, physiologic mechanisms, patient-reported outcomes, and biomarkers in women with operable breast cancer following the completion of definitive adjuvant therapy. METHODS/DESIGN: Using a single-center, randomized design, 174 postmenopausal women (58 patients/study arm) with histologically confirmed, operable breast cancer presenting to Duke University Medical Center (DUMC) will be enrolled in this trial following completion of primary therapy (including surgery, radiation therapy, and chemotherapy). After baseline assessments, eligible participants will be randomized to one of two supervised aerobic training interventions (moderate-intensity or moderate/high-intensity aerobic training) or an attention-control group (progressive stretching). The aerobic training interventions will include 150 mins.wk⁻¹ of supervised treadmill walking per week at an intensity of 60%-70% (moderate-intensity) or 60% to 100% (moderate to high-intensity) of the individually determined peak oxygen consumption (VO₂peak) between 20-45 minutes/session for 16 weeks. The progressive stretching program will be consistent with the exercise interventions in terms of program length (16 weeks), social interaction (participants will receive one-on-one instruction), and duration (20-45 mins/session). The primary study endpoint is VO₂peak, as measured by an incremental cardiopulmonary exercise test. Secondary endpoints include physiologic determinants that govern VO₂peak, patient-reported outcomes, and biomarkers associated with breast cancer recurrence/mortality. All endpoints will be assessed at baseline and after the intervention (16 weeks). DISCUSSION: EXCITE is designed to investigate the intensity of aerobic training required to induce optimal improvements in VO₂peak and other pertinent outcomes in women who have completed definitive adjuvant therapy for operable breast cancer. Overall, this trial will inform and refine exercise guidelines to optimize recovery in breast and other cancer survivors following the completion of primary cytotoxic therapy. TRIAL REGISTRATION: NCT01186367.
Type
Journal article
Subject
Biomarkers
Breast Neoplasms
Exercise
Exercise Therapy
Female
Humans
Oxygen
Oxygen Consumption
Postmenopause
Quality of Life
Randomized Controlled Trials as Topic
Research Design
Treatment Outcome
Walking
Permalink
https://hdl.handle.net/10161/4358
Published Version (Please cite this version)
10.1186/1471-2407-10-531
Publication Info
Jones, Lee W; Douglas, Pamela S; Eves, Neil D; Marcom, P Kelly; Kraus, William E; Herndon, James E; ... Peppercorn, Jeffrey (2010). Rationale and design of the Exercise Intensity Trial (EXCITE): A randomized trial comparing the effects of moderate versus moderate to high-intensity aerobic training in women with operable breast cancer. BMC Cancer, 10. pp. 531. 10.1186/1471-2407-10-531. Retrieved from https://hdl.handle.net/10161/4358.
This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.
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Scholars@Duke

Jason David Allen

Adjunct Associate Professor in the Department of Community and Family Medicine
My research is focused on investigating vascular physiology and oxygen radical biochemistry in health and disease. This combination allows examination of changes in vascular signaling mechanisms at a basic level to be translated to physiological responses. I direct the Frederick R. Cobb Non-Invasive Vascular Research Laboratory at the Center for Living Campus and have Biochemistry space in GSRB1. My group is involved in collaborations with several other research groups and the
This author no longer has a Scholars@Duke profile, so the information shown here reflects their Duke status at the time this item was deposited.
Douglas

Pamela Susan Douglas

Ursula Geller Distinguished Professor for Research in Cardiovascular Disease, in the School of Medicine
Pamela S Douglas MD is the Ursula Geller Professor of Research in Cardiovascular Diseases in the Department of Medicine at Duke University and Director of the Multimodality Imaging Program at Duke Clinical Research Institute. During her 30+ years of experience she has led several landmark multicenter government studies and pivotal industry clinical trials along with outcomes research studies.  She is renowned for her scientific and policy work in improving the quality and appropriateness
Herndon

James Emmett Herndon II

Professor of Biostatistics & Bioinformatics
Current research interests have application to the design and analysis of cancer clinical trials. Specifically, interests include the use of time-dependent covariables within survival models, the design of phase II cancer clinical trials which minimize some of the logistical problems associated with their conduct, and the analysis of longitudinal studies with informative censoring (in particular, quality of life studies of patients with advanced cancer).
Inman

Brant Allen Inman

Professor of Surgery
Clinical research interests: Clinical trials of novel diagnostic tests and therapies for genitourinary malignancies, with a strong focus on bladder cancer. Basic science research interests: Immune therapies for cancer, hyperthermia and heat-based treatment of cancer, molecular biology of genitourinary cancers, novel diagnostics and therapies for genitourinary cancers

Lee W Jones

Adjunct Associate Professor in the Department of Psychiatry & Behavioral Sciences
This author no longer has a Scholars@Duke profile, so the information shown here reflects their Duke status at the time this item was deposited.
Kraus

William Erle Kraus

Richard and Pat Johnson University Distinguished Professor
My training, expertise and research interests range from human integrative physiology and genetics to animal exercise models to cell culture models of skeletal muscle adaptation to mechanical stretch. I am trained clinically as an internist and preventive cardiologist, with particular expertise in preventive cardiology and cardiac rehabilitation.  My research training spans molecular biology and cell culture, molecular genetics, and integrative human exercise physiology and metabolism. I pr
Marcom

Paul Kelly Marcom

Adjunct Professor in the Department of Medicine
Basic Science: -Germline and somatic genetic changes in breast cancer. Translational: -Identification and management of individuals and families with hereditary cancer risk. -Communication of cancer risk information to individuals and families. -Breast cancer prevention. -Optimizing management of early breast cancer. -Treatment of metastatic breast cancer Clinically, Dr. Marcom works as a medical oncologist in the multidisciplina
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