Aerobic Training in Metastatic Breast Cancer (Breast Mets)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Memorial Sloan Kettering Cancer Center.
Duke University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center. Identifier:
First received: July 28, 2011
Last updated: January 15, 2015
Last verified: January 2015

This study is being done to examine the safety and feasibility of a supervised progressive exercise program in women diagnosed with metastatic breast cancer. Previous research among women with metastatic breast cancer has shown that some of the treatments commonly used in this population may have an adverse impact on physical fitness levels leading to feelings of fatigue and poor quality of life. Supervised exercise training has been shown to reduce some of these side-effects in women with early-stage breast cancer receiving common cancer treatments. However, it is not known if supervised exercise training is a safe and feasible intervention in women with metastatic breast cancer. This study is designed to find out if supervised exercise training is safe as the patients undergo treatments for metastatic breast cancer. This is the reason for this study.

Condition Intervention
Metastatic Breast Cancer
Behavioral: Progressive Stretching Group
Behavioral: Nonlinear Aerobic Training (will be prescribed according to ASCM guidelines)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Phase II Trial of Aerobic Training in Metastatic Breast Cancer

Resource links provided by NLM:

Further study details as provided by Memorial Sloan Kettering Cancer Center.:

Primary Outcome Measures:
  • Aerobic Training [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    To determine the feasibility and safety of nonlinear 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

Secondary Outcome Measures:
  • Treatment toxicities and Patient Symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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

Estimated Enrollment: 72
Study Start Date: December 2010
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Progressive Stretching Group Behavioral: Progressive Stretching Group
The progressive stretching program will be prescribed according to ASCM guidelines for older adults and aimed at increasing whole-body flexibility The ultimate goal for the progressive stretching program is 3 stretching sessions/week for 30-45 minutes/session (i.e., the same duration as aerobic training sessions). Stretching will be performed on stretching mats (i.e., no machines). Patients will be progressively trained to perform stretching exercises alternating between lower and upper body muscle groups / joints. Stretches will consist of prolonged holds held (under the maximum range of passive motion) initially for 20 secs and increasing to ≥60 secs/stretch. Subjects in the attention-control group may continue to walk at the casual levels, but will be encouraged not to increase exercise levels in addition to the supervised program.
Experimental: Nonlinear Aerobic Training Behavioral: Nonlinear Aerobic Training (will be prescribed according to ASCM guidelines)
The ultimate goal for the aerobic training group is 3 supervised treadmill-based exercise sessions per week at 50% to 80% of the individually determined exercise capacity (VO2peak; determined from the CPET performed at baseline and week 6) for 20-45 minutes/session for 12 weeks. In weeks 1-3 (i.e., introductory phase), the goal will be 3 aerobic training sessions / week, to introduce aerobic training, including warm-up, heart rate and rate of perceived exertion monitoring, as well as proper form. The aim will be to increase the duration of the exercise with the aim of increasing VO2peak. In weeks 4 to 6 (i.e., intermediate phase), participants will be asked to train 3 times a week. From week 7 onwards (i.e., maintenance phase), similar to the intermediate phase, participants will be asked to perform 3 aerobic sessions per week except sessions will be at least 25 minutes in duration at between 55% to 85% of baseline or mid-point VO2peak.


Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with histologically confirmed ER+, HER2+, or 'triple negative' MBC by MSKCC pathologist
  • Measurable disease (or nonmeasurable bone-only disease) assessed by CT or PET/CT within a maximum of 4 weeks prior to study entry;
  • ≥18 years of age;
  • Life expectancy >3 months; Performance status 0 or 1, as assessed by the ECOG scoring system;
  • 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) verified by the Exercise Behavior Questionnaire;
  • Normal cardiac function (left ventricular ejection fraction ≥50%);
  • Medical clearance from attending oncologist indicating no relative contraindications to undergo a symptom-limited cardiopulmonary exercise test and aerobic training intervention;
  • Patients with "treated and stable" brain lesions of a duration of > 2 months may be enrolled
  • Able to complete an acceptable cardiopulmonary exercise test defined as follows: achieving a plateau in oxygen consumption concurrent with an increase in power output, or a respiratory exchange ratio ≥ 1.1; volitional exhaustion, and a rating of perceived exertion greater than 18
  • English-speaking.
  • Female

Exclusion Criteria:

Any of the following absolute contraindications to cardiopulmonary exercise testing and/or aerobic training:


  • Acute myocardial Infarction (within 3-5 days of any planned study procedures);
  • Unstable angina;
  • Uncontrolled arrhythmia causing symptoms or hemodynamic compromise;
  • Recurrent syncope;
  • Active endocarditis;
  • Acute myocarditis or pericarditis;
  • Symptomatic severe aortic stenosis;
  • Uncontrolled heart failure;
  • Acute (within 3 months) pulmonary embolus or pulmonary infarction;
  • Thrombosis of lower extremities;
  • Suspected dissecting aneurysm;
  • Uncontrolled asthma;
  • Pulmonary edema;
  • Room air desaturation at rest ≤85%;
  • Respiratory failure;
  • Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (ie infection, renal failure, thyrotoxicosis); and
  • Mental impairment leading to inability to cooperate. - 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. However, patients with more than 5 bony sites may be deemed eligible at the discretion of the attending oncologist.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01725633

Contact: Lee Jones, PhD 646-888-4698
Contact: Neil Iyengar, MD 646-888-4714

United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Lee Jones, PhD    646-888-4698      
Contact: Neil Iyengar, MD    646-888-4714      
Principal Investigator: Lee Jones, PhD         
United States, North Carolina
Duke University Medical Center Active, not recruiting
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center.
Duke University
Principal Investigator: Lee Jones, PhD Memorial Sloan Kettering Cancer Center.
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan Kettering Cancer Center. Identifier: NCT01725633     History of Changes
Obsolete Identifiers: NCT02239848
Other Study ID Numbers: MSKCC 14-170
Study First Received: July 28, 2011
Last Updated: January 15, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan Kettering Cancer Center.:
Nonlinear Aerobic Training
14-170 processed this record on March 26, 2015