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Exercise Intervention Study for Early-Stage Breast Cancer Patients Receiving Neoadjuvant Therapy.

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ClinicalTrials.gov Identifier: NCT00405678
Recruitment Status : Completed
First Posted : November 30, 2006
Last Update Posted : July 11, 2014
United States Department of Defense
Information provided by (Responsible Party):
Duke University

Brief Summary:
To determine the effects of endurance exercise training on cardiopulmonary fitness in breast cancer patients undergoing neoadjuvant chemotherapy.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Exercise Training Behavioral: Chemo only Phase 1 Phase 2

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Exercise Training on Tumor Vascularity and Response to Neoadjuvant Therapy in Operable Breast Cancer: A Phase I-II Study
Study Start Date : September 2006
Actual Primary Completion Date : February 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Subjects receiving chemo and exercise training
Behavioral: Exercise Training
Subjects receiving chemo with exercise training

Experimental: 2
Subjects receiving chemo only
Behavioral: Exercise Training
Subjects receiving chemo with exercise training

Behavioral: Chemo only
Subjects receiving chemo only

Primary Outcome Measures :
  1. Determine effects of endurance exercise training on cardiopulmonary fitness via a stress test [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Adherence to fitness program [ Time Frame: 3 months ]
  2. Quality of life as determined by the (Functional Assessment of Cancer Therapy-Breast) FACT-B scale. [ Time Frame: 3 months ]
  3. Determine and define feasibility for an adequately powered Phase III study. [ Time Frame: 3 months ]
  4. Determine effects of exercise training on tumor vascularity, systemic response and tumor response. [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405678

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
United States Department of Defense
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Principal Investigator: Lee W Jones, PhD Duke University
American Cancer Society (2005). Cancer: Facts and Figures. ACS, Atlanta, GA.

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00405678    
Other Study ID Numbers: Pro00007112
8426 ( Other Identifier: Duke legacy protocol number )
First Posted: November 30, 2006    Key Record Dates
Last Update Posted: July 11, 2014
Last Verified: July 2013
Keywords provided by Duke University:
Exercise Intervention
Breast Cancer
Neo-Adjuvant Therapy
Operable Breast Cancer Stage I-II receiving neo-adjuvant chemotherapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases