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Metastatic Breast CancerBreast MetsNCT01725633

Aerobic Training in Metastatic Breast Cancer

A study testing Progressive Stretching Group, Nonlinear Aerobic Training and Blood draw in people with Metastatic Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Progressive Stretching Group, Nonlinear Aerobic Training and Blood draw
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
2 sitesUnited States
Study dates
Dec 2010to 4 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: Phase II Trial of Aerobic Training in Metastatic Breast Cancer

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.

Being tested
Progressive Stretching Group, Nonlinear Aerobic Training, Blood draw, Cardiopulmonary Exercise Testing (CPET)
Keywords
Stretching, Nonlinear Aerobic Training, 14-170
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Progressive Stretching GroupBehavioural

    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).

  • Nonlinear Aerobic TrainingBehavioural

    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 drawOther

    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.

Study groups in NCT01725633
Study groupRoleWhat they receive
Progressive Stretching GroupOtherNot described
Receives: Behavioral: Progressive Stretching Group; Other: Blood draw
Nonlinear Aerobic TrainingExperimentalNot described
Receives: Behavioral: Nonlinear Aerobic Training; Other: Blood draw; Other: Cardiopulmonary Exercise Testing (CPET)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

Secondary outcomes (1)

  1. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2012 (estimated)
  2. Study startDec 2010
  3. Primary completion4 Apr 2023
  4. Study completion4 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01725633
Sponsor's protocol ID
MSKCC 14-170
Acronym
Breast Mets
Status last verified
Apr 2023
First submitted
28 Jul 2011
Last updated
6 Apr 2023
Results posted
No

Publications

  • 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.

    PubMed 39270146

  • 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.

    PubMed 38485730

  • 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.

    PubMed 29624641

Questions about this trial

What is this clinical trial studying?

A study testing Progressive Stretching Group, Nonlinear Aerobic Training and Blood draw in people with Metastatic Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

safety of aerobic training (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01725633, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.

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