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Breast CancerNCT01943695

Supervised Aerobic Training During or After Chemotherapy for Operable Breast Cancer

A study testing Aerobic Training, Educational Information and Supervised Home Based Training in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to compare the effects of aerobic exercise training during and after chemotherapy for women who have recently been diagnosed with early-stage breast cancer. The participant will be instructed to self-report the session information to ExOnc staff at or before their next scheduled visit. Read more about this study

Who is it for?
Ages 21 to 80 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Aerobic Training, Educational Information and Supervised Home Based Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteUnited States
Study dates
Jan 2013to Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 21-80 years
  • Female
  • MSK histologically confirmed early-stage operable breast cancer
  • Scheduled to receive chemotherapy in the neoadjuvant or adjuvant setting
  • ECOG status of 0 or 1
  • Performing less than 150 minutes of structured moderate-intensity or strenuous intensity exercise per week
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  • If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study.
  • Women < 50 years old must have a negative pregnancy test (urine HCG or serum βHCG) within 2 weeks of beginning chemotherapy.
  • Able to complete an acceptable baseline cardiopulmonary exercise test (CPET), in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the investigator.
  • 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.
  • Willingness to be randomized to one of the study arms

Who cannot join

  • Presence of any other concurrent, actively treated malignancy
  • History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer)
  • Presence of metastatic disease
  • Any of the following contraindications to cardiopulmonary exercise testing:
  • Acute myocardial infarction within 3-5 days of any planned study procedures)
  • Unstable angina
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  • 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
  • Respiratory failure
  • Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis) or
  • Room air desaturation at rest ≤ 85%
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: Optimal Timing Trial: Randomized Trial of Supervised Aerobic Training During or After Chemotherapy for Operable Breast Cancer

The purpose of this study is to compare the effects of aerobic exercise training during and after chemotherapy for women who have recently been diagnosed with early-stage breast cancer.

The participant will be instructed to self-report the session information to ExOnc staff at or before their next scheduled visit. If the participant's next scheduled visit is greater than 72 hours following an unsupervised session, ExOnc staff may reach out to the participant to retrieve the session information. Unsupervised session details will be source documented by ExOnc staff.

Conditions
Breast Cancer
Being tested
Aerobic Training, Educational Information, Supervised Home Based Training
Keywords
Breast Cancer, Exercise, Chemotherapy, 15-178
Medical subject headings
Breast Neoplasms, Motor Activity

What participants receive

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

  • Aerobic TrainingBehavioural

    Also called exercise, breast cancer, therapy.

  • Educational InformationBehavioural

    Subjects will be given material regarding cancer and it's impact.

  • Supervised Home Based TrainingBehavioural

    Patients that elect supervised home based training platform or plan to complete unsupervised training sessions will receive a study kit which includes a heart rate monitor, blood pressure cuff, treadmill and tablet to complete aerobic training requirements. The study kit will be given to the patient upon completion of their baseline testing. The treadmill will be shipped to the patient's home and coordinated by the Ex Onc group. The treadmills are MSK owned equipment that will be deployed to the patient's homes via the vendor TechnoGym. A member of Ex Onc will provide an orientation session for the patient to set up all study kit items. If there is a delay in the patient receiving the treadmill , or any other unforeseen circumstance, patients may be assigned a temporary unsupervised training program until the treadmill is delivered.

Study groups in NCT01943695
Study groupRoleWhat they receive
Aerobic Training During ChemotherapyExperimentalThe ultimate goal is for participants to complete approximately 3 exercise sessions week of non-linear aerobic training an intensity of at 55% to 100% of the individually determined exercise capacity VO2peak), concurrent with chemotherapy. VO2peak will be determined by the CPET performed at baseline. The weekly exercise will be achieved via 3 individual aerobic training sessions ranging from approximately 20-45 min/session. All sessions are required to be supervised unless otherwise specified by EP discretion.
Receives: Behavioral: Aerobic Training
Aerobic Training After ChemotherapyExperimentalThe ultimate goal is for participants to complete approximately 3 exercise sessions week of non-linear aerobic training at an intensity 55% to 100% of the individually determined exercise capacity (VO2peak), after the completion of chemotherapy. VO2peak will be determined by the CPET performed at midpoint, or pre-surgery for neoadjuvant patients. For patients receiving adjuvant therapy, (except those who have additional surgery after chemotherapy), the aerobic training intervention must begin within 2 weeks of the patient's midpoint CPET. For patients receiving neoadjuvant or adjuvant therapy and have additional surgery after chemotherapy, the aerobic training intervention will begin within approximately 6 weeks of surgery, per the discretion of the treating physician. The weekly exercise will be achieved via 3 individual aerobic training sessions ranging from approximately 20-45 min/session. All sessions are required to be supervised unless otherwise specified by EP discretion.
Receives: Behavioral: Aerobic Training
Continuous Aerobic TrainingExperimentalThe ultimate goal is for participants to complete 3 exercise sessions week of non-linear aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), during and after chemotherapy. For patients receiving adjuvant therapy (except those who have additional surgery after chemotherapy), VO2peak will be determined by the CPETs performed at baseline and midpoint. For patients receiving neoadjuvant or adjuvant therapy and have additional surgery after chemotherapy, VO2peak will be determined by the CPETs or at baseline, pre- surgery, and post-surgery. The weekly exercise will be achieved via 3 individual aerobic training sessions ranging from approximately 20-45 min/session. All sessions are required to be supervised unless otherwise specified by EP discretion.
Receives: Behavioral: Aerobic Training
General Physical Activity GroupExperimentalPatients will receive a home-based, general physical activity program. Specifically, all patients assigned to general physical activity will receive an initial, consultation with a staff exercise physiologist outlining a structured home-based aerobic walking program with a goal up to 150 minutes per week outside of their normal daily activity. Patients can be provided with a fitness tracker (e.g. FitBit) to evaluate exercise duration and intensity. Patients may also be provided with an exercise log to record type, duration, and average heart rate during sessions. The exercise log is provided as a guidance tool and may be, although is not required to be, returned to study staff. Staff exercise physiologists will contact patients to check progress, and answer questions.
Receives: Behavioral: Educational Information; Behavioral: Supervised Home Based Training

What is being measured

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

  1. Change in VO2 peak (functional capacity)

    To determine the optimal timing of aerobic activity, relative to an attention-control group, on exercise capacity in a breast cancer setting. This will be evaluated using an electronic motorized treadmill test with 12-lead ECG monitoring (Mac® 5000, GE Healthcare) performed by certified exercise physiologists.

    Measured: during chemotherapy 3-6 months depending on treatment recommendations

Secondary outcomes (5)

  1. Quality of Life measured by questionnaire during and after Chemotherapy

    Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy.

    Measured: at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing

  2. Sleeping patterns as measured by questionnaire during and after Chemotherapy

    Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy.

    Measured: at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing

  3. Depression scale during and after Chemotherapy

    Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy.

    Measured: at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing

  4. Physical activity recall during and after Chemotherapy

    Determine the effects on patient-reported outcomes. Time frame can vary based on individual length of chemotherapy.

    Measured: at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing

  5. Skeletal Muscle Function

    To examine the physiological mediators of the exercise training - exercise capacity relationship (e.g., skeletal muscle function as assessed by a muscle biopsy)performed.

    Measured: at baseline, mid-point (12 weeks approximately) , and follow-up (24 weeks approximately) testing

Timeline

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

  1. First posted17 Sep 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionJun 2027 (estimated)
  4. Study completionAug 2027 (estimated)

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
Single group
Masking
None (open label)
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01943695
Sponsor's protocol ID
15-178
Status last verified
Jul 2026
First submitted
31 Jul 2013
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No

Publications

  • Iyengar NM, Scott JM, Lee J, Lavery JA, Foug KL, Lee CP, Michalski MG, Chun SS, Harrison J, Moskowitz CS, Jones LW. Effects of exercise therapy on chemotherapy delivery and response in primary breast cancer: A secondary analysis of a randomized trial. Cancer. 2025 Jan 1;131(1):e35575. doi: 10.1002/cncr.35575. Epub 2024 Sep 22.

    PubMed 39306704

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic Training, Educational Information and Supervised Home Based Training in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site 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 15 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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?

Change in VO2 peak (functional capacity) (time frame: during chemotherapy 3-6 months depending on treatment recommendations). 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 NCT01943695, which also lists 2 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 10 Jul 2026.

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