Exercise Intervention Study for Early-Stage Breast Cancer Patients Receiving Neoadjuvant Therapy.
NCT ID: NCT00405678
Last Updated: 2014-07-11
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE1/PHASE2
Total Enrollment
23 participants
Study Classification
INTERVENTIONAL
Study Start Date
2006-09-30
Study Completion Date
2010-09-30
Brief Summary
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To determine the effects of endurance exercise training on cardiopulmonary fitness in breast cancer patients undergoing neoadjuvant chemotherapy.
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Detailed Description
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Given that this is the first study to explore the potential effects of exercise training on exercise capacity, tumor vascularity and response in women undergoing neoadjuvant chemotherapy for operable breast cancer, prior to the initiation of the full investigation, we will conduct a small vanguard study to ensure we can achieve acceptable exercise adherence rates in the absence of dose-limiting toxicities (DLTs). Specifically, three operable breast cancer patients will be recruited and enrolled as described below and perform exercise training for a minimum of six weeks. If acceptable exercise rates are observed in the absence of severe DLTs during this time, we will proceed with the full investigation (recruitment of additional 20 patients) (see Figure 2). Using a prospective, randomized design, potential participants will be identified and screened for eligibility by an assigned Breast Protocol Nurse (TBD) via medical record review of patients scheduled for their primary neoadjuvant chemotherapy consultation at DCCC
Conditions
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Breast Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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1
Subjects receiving chemo and exercise training
Group Type
EXPERIMENTAL
Exercise Training
Intervention Type
BEHAVIORAL
Subjects receiving chemo with exercise training
2
Subjects receiving chemo only
Group Type
EXPERIMENTAL
Exercise Training
Intervention Type
BEHAVIORAL
Subjects receiving chemo with exercise training
Chemo only
Intervention Type
BEHAVIORAL
Subjects receiving chemo only
Interventions
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Exercise Training
Subjects receiving chemo with exercise training
Intervention Type
BEHAVIORAL
Chemo only
Subjects receiving chemo only
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed operable primary breast cancer
* Age 18 or older
* Karnofsky performance status greater than 70
* No previous malignancy
* Absence of significant cardiac disease (left ventricular ejection fraction greater than or equal to 50%)
* No hormonal replacement therapy use within the past month
* Not pregnant
* Ability to read and understand English
* Signed written informed consent prior to beginning protocol specific procedures
* Willing to travel to DUMC to exercise three times per week
* Primary treating oncologist approval
* Age 18 or older
* Karnofsky performance status greater than 70
* No previous malignancy
* Absence of significant cardiac disease (left ventricular ejection fraction greater than or equal to 50%)
* No hormonal replacement therapy use within the past month
* Not pregnant
* Ability to read and understand English
* Signed written informed consent prior to beginning protocol specific procedures
* Willing to travel to DUMC to exercise three times per week
* Primary treating oncologist approval
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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United States Department of Defense
FED
Sponsor Role
collaborator
Duke University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Lee W Jones, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Site Status
Countries
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United States
References
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Demark-Wahnefried W, Morey MC, Clipp EC, Pieper CF, Snyder DC, Sloane R, Cohen HJ. Leading the Way in Exercise and Diet (Project LEAD): intervening to improve function among older breast and prostate cancer survivors. Control Clin Trials. 2003 Apr;24(2):206-23. doi: 10.1016/s0197-2456(02)00266-0.
Reference Type
BACKGROUND
Godin G, Jobin J, Bouillon J. Assessment of leisure time exercise behavior by self-report: a concurrent validity study. Can J Public Health. 1986 Sep-Oct;77(5):359-62. No abstract available.
Reference Type
BACKGROUND
Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
Reference Type
BACKGROUND
Segal R, Evans W, Johnson D, Smith J, Colletta S, Gayton J, Woodard S, Wells G, Reid R. Structured exercise improves physical functioning in women with stages I and II breast cancer: results of a randomized controlled trial. J Clin Oncol. 2001 Feb 1;19(3):657-65. doi: 10.1200/JCO.2001.19.3.657.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
8426
Identifier Type: OTHER
Identifier Source: secondary_id
Pro00007112
Identifier Type: -
Identifier Source: org_study_id
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