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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00405678
Enrollment
23
Registered
2006-11-30
Start date
2006-09-30
Completion date
2010-09-30
Last updated
2014-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Exercise Intervention, Breast Cancer, Neo-Adjuvant Therapy, Operable Breast Cancer Stage I-II receiving neo-adjuvant chemotherapy

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

Interventions

BEHAVIORALChemo only

Subjects receiving chemo only

BEHAVIORALExercise Training

Subjects receiving chemo with exercise training

Sponsors

United States Department of Defense
CollaboratorFED
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Determine effects of endurance exercise training on cardiopulmonary fitness via a stress test3 months

Secondary

MeasureTime frame
Adherence to fitness program3 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026