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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00405678
First received: November 29, 2006
Last updated: July 9, 2014
Last verified: July 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Lee W Jones, PhD Duke University
  More Information

Publications:
van Diest, P.J., Vleugel, M.M., van der Wall, E., Currie, M.J., Hanrahan, V., Gunningham, S.P., Morrin, H.R., Frampton, C., Han, C., Robinson, B.A., and Fox, S.B. (2005). Expression of HIF-1{alpha} in human tumours. J Clin Pathol 58, 335-336.
Kingwell, B.A., Jennings, G.L., and Dart, A.M. (2000). Exercise and endothelial function. Circulation 102, E179.

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: July 9, 2014
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 September 30, 2014