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

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Exercise Training; Behavioral: Chemo only

• Registration Number: NCT00405678
• Lead Sponsor: Duke University

Brief Summary

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

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 Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-11-29
• Study First Submitted QC: 2006-11-29
• Study First Posted: 2006-11-30
• Primary Completion: 2010-02
• Study Completion: 2010-09
• Status Verified: 2013-07
• Last Update Submitted: 2014-07-09
• Last Update Posted: 2014-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Exercise Training	Subjects receiving chemo only
1	Exercise Training	Subjects receiving chemo and exercise training
2	Chemo only	Subjects receiving chemo only

Primary Outcome Measures

Name	Time	Method
Determine effects of endurance exercise training on cardiopulmonary fitness via a stress test	3 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States