Aerobic Training in Metastatic Breast Cancer (Breast Mets)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Memorial Sloan Kettering Cancer Center
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01725633
First received: July 28, 2011
Last updated: May 13, 2015
Last verified: May 2015
  Purpose

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 ACSM 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:
  • safety of aerobic training [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Safety will be evaluated by the type and prevalence of adverse events during study-related assessments as well as aerobic training and progressive stretching sessions. The NCI Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE) will be used to grade toxicities during the trial.


Secondary Outcome Measures:
  • feasibility of aerobic training [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    feasibility will be evaluated by examining several different end points including rates of study eligibility and accrual, etc; however, sample size calculations are based on an integration of aerobic training attendance rate (in the aerobic training group) as well as global trial attrition rates. Together, these end points will be used to determine overall study feasibility.


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 ACSM guidelines for older adults and aimed at increasing whole-body flexibility The ultimate goal for the progressive stretching program is three stretching sessions/week for 20-45 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 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 ACSM guidelines)
The ultimate goal for the aerobic training group is three 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 three times a week. From week 7 onwards (i.e., maintenance phase), similar to the intermediate phase, participants will be asked to perform three 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.

  Eligibility

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

Inclusion Criteria:

  • Patients with histologically confirmed MBC by MSKCC pathologist
  • Measurable disease (or nonmeasurable bone-only disease) assessed by CT or PET/CT performed as part of standard of care, at the discretion of the attending oncologist in the Breast Medicine Service
  • ≥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 or equal to 18
  • English-speaking and
  • 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 (i.e. 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 five 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 ClinicalTrials.gov identifier: NCT01725633

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

Locations
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
Investigators
Principal Investigator: Lee Jones, PhD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01725633     History of Changes
Obsolete Identifiers: NCT02239848
Other Study ID Numbers: MSKCC 14-170
Study First Received: July 28, 2011
Last Updated: May 13, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan Kettering Cancer Center:
Stretching
Nonlinear Aerobic Training
14-170

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on June 28, 2015