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.
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 articleSubject
BiomarkersBreast 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/10161/4358Published Version (Please cite this version)
10.1186/1471-2407-10-531Publication 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.
Collections
More Info
Show full item recordScholars@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.
Pamela Susan Douglas
Ursula Geller Distinguished Professor of Research in Cardiovascular Diseases
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
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).
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.
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
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
Alphabetical list of authors with Scholars@Duke profiles.

Articles written by Duke faculty are made available through the campus open access policy. For more information see: Duke Open Access Policy
Rights for Collection: Scholarly Articles
Works are deposited here by their authors, and represent their research and opinions, not that of Duke University. Some materials and descriptions may include offensive content. More info