Overview

This trial is active, not recruiting.

Condition metastatic breast cancer
Treatments progressive stretching group, nonlinear aerobic training, blood draw, cardiopulmonary exercise testing (cpet)
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator Duke University
Start date December 2010
End date November 2017
Trial size 27 participants
Trial identifier NCT01725633, MSKCC 14-170, NCT02239848

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Other)
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).
blood draw
At Weeks 4, and 8, all participants will have a complete blood count (CBC) test performed.
(Experimental)
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.
blood draw
At Weeks 4, and 8, all participants will have a complete blood count (CBC) test performed.
cardiopulmonary exercise testing (cpet)
At the end of Week 6, participants repeat the CPET in the nonlinear aerobic training group.

Primary Outcomes

Measure
safety of aerobic training
time frame: 2 years

Secondary Outcomes

Measure
feasibility of aerobic training
time frame: 2 years

Eligibility Criteria

Female participants at least 21 years old.

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.

Additional Information

Official title Phase II Trial of Aerobic Training in Metastatic Breast Cancer
Principal investigator Lee Jones, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.
Location data was received from the National Cancer Institute and was last updated in July 2016.