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| Name | Class |
|---|---|
| Duke University | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Progressive Stretching Group | Other |
| |
| Nonlinear Aerobic Training | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progressive Stretching Group | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| safety of aerobic training | 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| feasibility of aerobic training | 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. |
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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:
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:
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.](streamdown:incomplete-link)
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| Name | Affiliation | Role |
|---|---|---|
| Lee Jones, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States | ||
| Duke University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39270146 | Derived | Novo RT, Thomas SM, Khouri MG, Alenezi F, Herndon JE 2nd, Michalski M, Collins K, Nilsen T, Edvardsen E, Jones LW, Scott JM. Machine Learning-Driven Phenogrouping and Cardiorespiratory Fitness Response in Metastatic Breast Cancer. JCO Clin Cancer Inform. 2024 Sep;8:e2400031. doi: 10.1200/CCI.24.00031. | |
| 38485730 | Derived |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| Nonlinear Aerobic Training | Behavioral | 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 | Other | At Weeks 4, and 8, all participants will have a complete blood count (CBC) test performed. |
|
| Cardiopulmonary Exercise Testing (CPET) | Other | At the end of Week 6, participants repeat the CPET in the nonlinear aerobic training group. |
|
| 2 years |
| Durham |
| North Carolina |
| 27710 |
| United States |
| Scott JM, Lee J, Michalski MG, Batch K, Simpson AL, Peoples J, Lee CP, Harrison JN, Yu AF, Sasso JP, Dang C, Moskowitz CS, Jones LW, Eves ND. Mechanisms of Exercise Intolerance Across the Breast Cancer Continuum: A Pooled Analysis of Individual Patient Data. Med Sci Sports Exerc. 2024 Apr 1;56(4):590-599. doi: 10.1249/MSS.0000000000003348. Epub 2023 Nov 27. |
| 29624641 | Derived | Scott JM, Iyengar NM, Nilsen TS, Michalski M, Thomas SM, Herndon J 2nd, Sasso J, Yu A, Chandarlapaty S, Dang CT, Comen EA, Dickler MN, Peppercorn JM, Jones LW. Feasibility, safety, and efficacy of aerobic training in pretreated patients with metastatic breast cancer: A randomized controlled trial. Cancer. 2018 Jun 15;124(12):2552-2560. doi: 10.1002/cncr.31368. Epub 2018 Apr 6. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |