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

July 9, 2014 updated by: Duke University

The Effects of Exercise Training on Tumor Vascularity and Response to Neoadjuvant Therapy in Operable Breast Cancer: A Phase I-II Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine effects of endurance exercise training on cardiopulmonary fitness via a stress test
Time Frame: 3 months
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Lee W Jones, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

November 29, 2006

First Submitted That Met QC Criteria

November 29, 2006

First Posted (Estimate)

November 30, 2006

Study Record Updates

Last Update Posted (Estimate)

July 11, 2014

Last Update Submitted That Met QC Criteria

July 9, 2014

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00007112
  • 8426 (Duke legacy protocol number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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