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

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00405678
• Collaborator: United States Department of Defense (U.S. Fed)
• Enrollment: 23
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Behavioral: Exercise Training; Behavioral: Chemo only	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Determine effects of endurance exercise training on cardiopulmonary fitness via a stress test [3 months]

Secondary Outcome Measures

1. Adherence to fitness program [3 months]

2. Quality of life as determined by the (Functional Assessment of Cancer Therapy-Breast) FACT-B scale. [3 months]

3. Determine and define feasibility for an adequately powered Phase III study. [3 months]

4. Determine effects of exercise training on tumor vascularity, systemic response and tumor response. [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University
• United States Department of Defense

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT00405678
• Other Study ID Numbers: Pro00007112; 8426
• First Posted: Nov 30, 2006
• Last Update Posted: Jul 11, 2014
• Last Verified: Jul 1, 2013

• 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

Study Results

No Results Posted as of Jul 11, 2014