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Phase II Trial of Aerobic Training in Metastatic Breast Cancer


Phase 1
21 Years
80 Years
Open (Enrolling)
Female
Metastatic Breast Cancer

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Trial Information

Phase II Trial of Aerobic Training in Metastatic Breast Cancer


Primary To determine the feasibility and safety of supervised aerobic training in women
receiving endocrine therapy, chemotherapy, and/or radiotherapy for metastatic breast cancer

Secondary

- To explore the potential effect (means and variation) on treatment toxicity, patient
symptoms, and functional capacity, relative to attention control (i.e., mock exercise)

- To explore the potential effect (means and variation) on biomarkers associated with
metastatic breast cancer prognosis (i.e., inflammatory cytokines and growth factors),
relative to attention control

Primary: Safety and feasibility evaluated by assessing the rates of study eligibility,
overall accrual, attrition, and exercise adherence. Safety will be evaluated by the type and
prevalence of adverse events during study-related assessments and aerobic training sessions.
Tracking and monitoring of exercise-related adverse events will be assessed using the
following methods: (1) stringent monitoring and recording (in the patient case report form;
case report form, this will include a detailed past medical history, complete blood count
panel history from first line chemotherapy, and detailed medication information) of
physiologic outcomes and vital signs (e.g., heart rate, blood pressure, etc.) prior to,
during, and following every intervention session, and (2) at the beginning of each week, the
exercise physiologist will spend the first 10 minutes of every session discussing any
potential negative side-effects of the intervention assignment and any injuries that may
have occurred. Discussions will include topics such as sleep, depression, diet, exercise,
and any other related topics that should come up. All events will be recorded in the
patient CRF, (3) every two weeks all patients will complete the Common Terminology Criteria
for Adverse Events (CTCAE) v4.0 questionnaire. The CTCAE, developed by the NCI, tracks
treatment toxicity and adverse events applicable to all oncology clinical trials regardless
of chronicity or modality, (4) every three months a meeting of all investigators will be
scheduled to review and discuss all reported non-serious and serious adverse events for
early identification of negative issues and development of solutions. All serious adverse
events will be immediately reported to Duke Institutional Review Board and immediately
circulated to all study investigators for appropriate discussion, and (5) early stopping
rules in response to a differential higher frequency of adverse events in a particular study
group (Risk outweighs benefit as determined by primary investigator and oncologist).

Secondary:

1. Treatment toxicity and complete blood count panel will be assessed after every
chemotherapy cycle or every month if on hormone or radiation therapy according to the
CTCAE v.4.0 as described above.

2. Insulin sensitivity as assessed by an oral glucose tolerance test,

3. Exercise capacity as measured by a symptom-limited cardiopulmonary exercise test,

4. Pulmonary function as assessed by hand held spirometry,

5. Cardiac function as assessed by echocardiography at rest and exercise,

6. Neurocognitive function (a computerized neurocognitive test battery called Central
Nervous System Vital Signs including verbal memory test, visual memory test, finger
tapping test, symbol digit coding, Stroop test, shifting attention test, continuous
performance test, four part continuous performance test).

7. Autonomic function as assessed by beat-to-beat heart, blood pressure, and
cerebrovascular blood flow velocity via transcranial Doppler.

8. Patient-reported outcomes will be determined using standardized and validated
questionnaires to assess quality of life, fatigue, and other common patient symptoms.

9. Systemic Cytokines / Angiogenic Factors assessed in fasted blood and prepared for
multiplex assay analysis using Luminex 100/200 System (Luminex Corp, Austin, Tx;
http://www.luminexcorp.com/products/luminex_200.html).


Inclusion Criteria:



Consecutive women with histologically confirmed or cytologically confirmed metastatic
breast cancer (MBC) presenting at Duke University Medical Center (DUMC), Durham Regional
Hospital, or Duke Raleigh will be potentially eligible. Other major specific inclusion
criteria are as follows:

1. Candidates receiving hormone therapy, chemotherapy, and/or radiotherapy for MBC

2. Complete radiology and tumor measurement within a maximum of 4 weeks prior to study
entry,

3. ≥21 years of age,

4. Life expectancy >3 months to ensure recruited patients can complete the 3-month
intervention,

5. Performance status ≥70%, as assessed by the Karnofsky performance status (KPS)
scoring system. KPS involves the subjective evaluation of patients' global physical
functioning and capability of independent living and self-care as determined by
oncology professionals,

6. Sedentary (i.e., women not performing regular exercise on at least 5 days a week, for
at least 30 minutes each session, at a moderate or vigorous intensity for the past
month). This definition is consistent with the national exercise recommendations
guidelines and will ensure that only women not currently engaging in regular exercise
(i.e., those who are the most likely to benefit) are recruited,

7. Normal cardiac function (left ventricular ejection fraction ≥50%), and

8. Medical clearance from attending oncologist to undergo supervised exercise training.

Previous treatment with an anthracycline, taxane, angiogenesis inhibition, or hormonal
therapy in the neoadjuvant or adjuvant setting is allowed.

-

Exclusion Criteria:

1. Radiographic evidence of central nervous system disease, and 2. Contraindications to
aerobic training (e.g., extensive skeletal metastases, coronary artery disease, severe
anemia, etc.) as recommended for cancer patients.43 Extensive skeletal metastases will be
defined for purposes of this study as greater than five (5) sites of bony disease, or any
symptomatic site of disease in the spine, hip, or femur. As above, all patients must
additionally receive medical clearance to undergo a trial of supervised exercise for MBC
from their primary attending oncologist.

-

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Aerobic Training

Outcome Description:

To determine the feasibility and safety of supervised aerobic training in women receiving endocrine therapy, chemotherapy, and/or radiotherapy for metastatic breast cancer. Safety and feasibility evaluated by assessing the rates of study eligibility, overall accrual, attrition, and exercise adherence. Safety will be evaluated by the type and prevalence of adverse events during study-related assessments and aerobic training sessions. Tracking and monitoring of exercise-related adverse events will be assessed using the following methods: (1) stringent monitoring and recording (in the patient case report form; case report form, this will include a detailed past medical history, complete blood count panel history from first line chemotherapy, and detailed medication information) of physiologic outcomes and vital signs (e.g., heart rate, blood pressure, etc.) prior to, during, and following every intervention session

Outcome Time Frame:

3 months

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

Pro00025906

NCT ID:

NCT01725633

Start Date:

December 2010

Completion Date:

November 2013

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms

Name

Location

Duke University Medical CenterDurham, North Carolina  27710