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Aerobic Training in Metastatic Breast Cancer (Breast Mets)

Primary Purpose

Metastatic Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Progressive Stretching Group
Nonlinear Aerobic Training
Blood draw
Cardiopulmonary Exercise Testing (CPET)
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metastatic Breast Cancer focused on measuring Stretching, Nonlinear Aerobic Training, 14-170

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan Kettering Cancer Center
  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Progressive Stretching Group

Nonlinear Aerobic Training

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 28, 2011
Last Updated
April 4, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT01725633
Brief Title
Aerobic Training in Metastatic Breast Cancer
Acronym
Breast Mets
Official Title
Phase II Trial of Aerobic Training in Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
April 4, 2023 (Actual)
Study Completion Date
April 4, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Duke University

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
Stretching, Nonlinear Aerobic Training, 14-170

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progressive Stretching Group
Arm Type
Other
Arm Title
Nonlinear Aerobic Training
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Progressive Stretching Group
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Nonlinear Aerobic Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Blood draw
Intervention Description
At Weeks 4, and 8, all participants will have a complete blood count (CBC) test performed.
Intervention Type
Other
Intervention Name(s)
Cardiopulmonary Exercise Testing (CPET)
Intervention Description
At the end of Week 6, participants repeat the CPET in the nonlinear aerobic training group.
Primary Outcome Measure Information:
Title
safety of aerobic training
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
feasibility of aerobic training
Description
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.
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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: Achieving a plateau in oxygen consumption, concurrent with an increase in power output; A respiratory exchange ratio ≥ 1.10; Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax [HRmax = 220-Age[years]); 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: 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 pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures 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) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Jones, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29624641
Citation
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.
Results Reference
derived
Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

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Aerobic Training in Metastatic Breast Cancer

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