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

This study has been completed.

Sponsor:

Collaborator:

Department of Defense

Information provided by (Responsible Party):

Duke University

ClinicalTrials.gov Identifier:

NCT00405678

First received: November 29, 2006

Last updated: January 15, 2013

Last verified: November 2012

History of Changes

Purpose

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

Condition	Intervention	Phase
Breast Cancer	Behavioral: Exercise Training Behavioral: Chemo only	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

Determine effects of endurance exercise training on cardiopulmonary fitness via a stress test [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adherence to fitness program [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Quality of life as determined by the (Functional Assessment of Cancer Therapy-Breast) FACT-B scale. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Determine and define feasibility for an adequately powered Phase III study. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Determine effects of exercise training on tumor vascularity, systemic response and tumor response. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment:	23
Study Start Date:	September 2006
Study Completion Date:	September 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405678

Locations

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

Department of Defense

Investigators

Principal Investigator:

Lee W Jones, PhD

Duke University

More Information

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Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT00405678 History of Changes
Other Study ID Numbers:	Pro00007112 (8426)
Study First Received:	November 29, 2006
Last Updated:	January 15, 2013
Health Authority:	United States: Institutional Review Board

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:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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