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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405678
• Other study ID #: Pro00007112
• Secondary ID: 8426
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 29, 2006
• Last updated: July 9, 2014
• Start date: September 2006
• Est. completion date: September 2010

Study information

• Verified date: July 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Exercise Training
Subjects receiving chemo with exercise training
• Chemo only
Subjects receiving chemo only

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	United States Department of Defense

Country where clinical trial is conducted

United States, 

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* Note: There are 78 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine effects of endurance exercise training on cardiopulmonary fitness via a stress test		3 months	No
Secondary	Adherence to fitness program		3 months	No
Secondary	Quality of life as determined by the (Functional Assessment of Cancer Therapy-Breast) FACT-B scale.		3 months	No
Secondary	Determine and define feasibility for an adequately powered Phase III study.		3 months	No
Secondary	Determine effects of exercise training on tumor vascularity, systemic response and tumor response.		3 months	No