Aerobic Training in Metastatic Breast Cancer (Breast Mets)

This study is ongoing, but not recruiting participants.
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: June 16, 2016
Last verified: June 2016
  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.

Condition Intervention
Metastatic Breast Cancer
Behavioral: Progressive Stretching Group
Behavioral: Nonlinear Aerobic Training
Other: Blood draw
Other: Cardiopulmonary Exercise Testing (CPET)

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.


Enrollment: 27
Study Start Date: December 2010
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Progressive Stretching Group Behavioral: Progressive Stretching Group
Participants assigned to the progressive stretching group will be provided with a progressive stretching program that matches the aerobic training interventions in terms of program length (16 weeks), social interaction (all sessions will be supervised), and session duration (20-45 minutes/session, ± 10 minutes).
Other: Blood draw
At Weeks 4, and 8, all participants will have a complete blood count (CBC) test performed.
Experimental: Nonlinear Aerobic Training Behavioral: Nonlinear Aerobic Training
Participants assigned to the nonlinear aerobic training arm will perform no more than 150 minutes per week of structured supervised aerobic training as part of clinical trial participation. Exercise performed outside the structured sessions (i.e., contamination) will be assessed via self-report of exercise behavior using the Godin-Leisure Time Exercise Questionnaire (GLTEQ). For ethical reasons, we will not instruct participants not to exercise outside the structured sessions, but we we will encourage participants to maintain their level of exercise behavior prior to study initiation.
Other: Blood draw
At Weeks 4, and 8, all participants will have a complete blood count (CBC) test performed.
Other: Cardiopulmonary Exercise Testing (CPET)
At the end of Week 6, participants repeat the CPET in the nonlinear aerobic training group.

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • MSK histologically confirmed metastatic breast cancer
  • 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;
  • ECOG ≤ 1
  • Sedentary, as per the leisure score index (LSI) of the Godin Leisure-Time Exercise Questionnaire (GLTEQ) . Participants who perform regular moderate or vigorous intensity exercise at least 5 days/week, for at least 30 minutes/session, are not eligible
  • Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria:

    1. Achieving a plateau in oxygen consumption, concurrent with an increase in power output;
    2. A respiratory exchange ratio ≥ 1.10;
    3. Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax [HRmax = 220-Age[years]);
    4. Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale
  • 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
  • Willing to be randomized to one of the study arms
  • Female

Exclusion Criteria:

  • Any of the following absolute contraindications to cardiopulmonary exercise testing:

    1. Acute myocardial infarction within 3-5 days of any planned study procedures
    2. Unstable angina
    3. Uncontrolled arrhythmia causing symptoms or hemodynamic compromise;
    4. Recurrent syncope
    5. Active endocarditis;
    6. Acute myocarditis or pericarditis
    7. Symptomatic severe aortic stenosis
    8. Uncontrolled heart failure
    9. Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures
    10. Thrombosis of lower extremities
    11. Suspected dissecting aneurysm
    12. Uncontrolled asthma
    13. Pulmonary edema
    14. Room air desaturation at rest ≤ 85%
    15. Respiratory failure
    16. Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)
    17. Mental impairment leading to inability to cooperate.
  • Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial
  • Presence of extensive skeletal metastases, defined as more than five (5) sites of bony disease, or any symptomatic site of disease in the spine, hip, or femur. Note that, 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

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center
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:
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: June 16, 2016
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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 22, 2016