Breast CancerExciteNCT01186367
Trial Comparing the Effects of Linear Versus Nonlinear Aerobic Training in Women With Operable Breast Cancer
A study testing Linear Aerobic Training, Nonlinear Aerobic Training and Progressive Stretching in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to compare the effects of 3 different approaches to exercise training in women with early stage breast cancer who have completed all primary treatments (except hormone therapy, if appropriate). Read more about this study
- Who is it for?
- Ages 45 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Linear Aerobic Training, Nonlinear Aerobic Training and Progressive Stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2010to 17 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 45-80 years
- Female
- Has been diagnosed with early-stage breast cancer
- Post-menopausal, defined as :
- Age ≥ 45 with no menses for at least 2 years
- Chemically induced menopause through ovarian suppression, as determined by the primary oncologist
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- An interval of at least one year, but no more than five years, following the full completion of primary therapy for malignant disease. Primary therapy is defined as:
- Surgery plus radiation
- Surgery plus chemotherapy
- Surgery plus trastuzumab
- Surgery plus hormone therapy Note: For patients who receive hormone therapy following surgery, the definition of one-year post-completion of therapy is defined by the surgery date. Patients who are currently receiving hormone therapy are eligible for enrollment.
- Weight of < 205 kgs
- ECOG status of 0 or 1
- Life expectancy ≥ 6 months
- Performing less than 150 minutes of structured moderate-intensity or strenuous intensity exercise per week.
- Exercise intolerance defined by a VO2peak below that predicted for sedentary age and sex-matched individuals as defined in Appendix H.
- Willing to be randomized to one of the study arms
- Able to complete an acceptable baseline 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.
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;
- Respiratory failure;
- Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis);
- 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
- 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
About this study
Official title: Exercise Intensity Trial (EXCITE): A Randomized Trial Comparing the Effects of Linear Versus Nonlinear Aerobic Training in Women With Operable Breast Cancer
The purpose of this study is to compare the effects of 3 different approaches to exercise training in women with early stage breast cancer who have completed all primary treatments (except hormone therapy, if appropriate). Prior research in women with early stage breast cancer has shown that some treatments 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. However, all the exercise programs have followed essentially the same approach. This study is designed to see if a different approach to exercise training is more effective than the conventional approach currently in use.
- Conditions
- Breast Cancer
- Being tested
- Linear Aerobic Training, Nonlinear Aerobic Training, Progressive Stretching, Cardiopulmonary exercise test (CPET), Blood draws
- Keywords
- breast cancer, Linear Versus Nonlinear Aerobic Training, 15-147
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linear Aerobic TrainingBehavioural
The 130-180 minutes/week will be achieved via either 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes per/session (± 10 minutes).
Nonlinear Aerobic TrainingBehavioural
The 130-180 minutes/week will be achieved via 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes/ per session (+/- 10 minutes).
Progressive StretchingBehavioural
All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.
Cardiopulmonary exercise test (CPET)Other
Blood drawsOther
Complete blood count
| Study group | Role | What they receive |
|---|---|---|
| Linear Aerobic Training | Experimental | The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training, at 60% to 75 % of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at baseline. Receives: Behavioral: Linear Aerobic Training; Other: Cardiopulmonary exercise test (CPET); Other: Blood draws |
| Nonlinear Aerobic Training | Experimental | The ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at Baseline and as well as the CPET performed at Midpoint. Receives: Behavioral: Nonlinear Aerobic Training; Other: Cardiopulmonary exercise test (CPET); Other: Blood draws |
| Progressive Stretching Group (Attention control) | Experimental | The ultimate goal for the progressive stretching program is 3 to 4 individual stretching sessions/week for 10 to 50 minutes per session (+/- 10 minutes). Receives: Behavioral: Progressive Stretching; Other: Cardiopulmonary exercise test (CPET); Other: Blood draws |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.
VO2 or peak oxygen consumption will be measured at Baseline
Measured: Baseline
To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.
VO2 or peak oxygen consumption for nonlinear aerobic training will be measured at mid-point (8 weeks)
Measured: 8 weeks
To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.
VO2 or peak oxygen consumption will be measured at post-intervention (16 weeks).
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study start11 Nov 2010
- Primary completion17 May 2023
- Study completion17 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Jessica Scott, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186367
- Sponsor's protocol ID
- 15-147
- Acronym
- Excite
- Status last verified
- Mar 2024
- First submitted
- 19 Aug 2010
- Last updated
- 10 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Scott JM, Thomas SM, Peppercorn JM, Herndon JE 2nd, Douglas PS, Khouri MG, Dang CT, Yu AF, Catalina D, Ciolino C, Capaci C, Michalski MG, Eves ND, Jones LW. Effects of Exercise Therapy Dosing Schedule on Impaired Cardiorespiratory Fitness in Patients With Primary Breast Cancer: A Randomized Controlled Trial. Circulation. 2020 Feb 18;141(7):560-570. doi: 10.1161/CIRCULATIONAHA.119.043483. Epub 2020 Feb 17.
PubMed 32065769Scott 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 38485730Michalski M, Rowed K, Lavery JA, Moskowitz CS, Capaci C, Stene G, Edvardsen E, Eves ND, Jones LW, Scott JM. Validity of Estimated Cardiorespiratory Fitness in Patients With Primary Breast Cancer. JACC CardioOncol. 2022 Jun 21;4(2):210-219. doi: 10.1016/j.jaccao.2022.05.003. eCollection 2022 Jun.
PubMed 35818548Jones LW, Douglas PS, Eves ND, Marcom PK, Kraus WE, Herndon JE 2nd, Inman BA, Allen JD, Peppercorn J. Rationale and design of the Exercise Intensity Trial (EXCITE): A randomized trial comparing the effects of moderate versus moderate to high-intensity aerobic training in women with operable breast cancer. BMC Cancer. 2010 Oct 6;10:531. doi: 10.1186/1471-2407-10-531.
PubMed 20925920
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Intensity Trial (EXCITE): A Randomized Trial Comparing the Effects of Linear Versus Nonlinear Aerobic Training in Women With Operable Breast Cancer
- ClinicalTrials.gov ID
- NCT01186367
- Acronym / sponsor ID
- Excite / 15-147
- Conditions
- Breast Cancer
- Keywords
- breast cancer, Linear Versus Nonlinear Aerobic Training, 15-147
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Duke University
- Study start
- 11 Nov 2010 (actual)
- Primary completion
- 17 May 2023 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 23 Aug 2010 (estimated)
- Results
- Posted 10 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effects of 3 different approaches to exercise training in women with early stage breast cancer who have completed all primary treatments (except hormone therapy, if appropriate). Prior research in women with early stage breast cancer has shown that some treatments 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. However, all the exercise programs have followed essentially the same approach. This study is designed to see if a different approach to exercise training is more effective than the conventional approach currently in use.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Linear Aerobic Training | Experimental | Behavioral: Linear Aerobic Training, Other: Cardiopulmonary exercise test (CPET), Other: Blood drawsThe ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training, at 60% to 75 % of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at baseline. |
| Nonlinear Aerobic Training | Experimental | Behavioral: Nonlinear Aerobic Training, Other: Cardiopulmonary exercise test (CPET), Other: Blood drawsThe ultimate goal is for participants to complete approximately 130-180 minutes/week of aerobic training at 55% to 100% of the individually determined exercise capacity (VO2peak), for 16 weeks. VO2peak will be determined by the second CPET performed at Baseline and as well as the CPET performed at Midpoint. |
| Progressive Stretching Group (Attention control) | Experimental | Behavioral: Progressive Stretching, Other: Cardiopulmonary exercise test (CPET), Other: Blood drawsThe ultimate goal for the progressive stretching program is 3 to 4 individual stretching sessions/week for 10 to 50 minutes per session (+/- 10 minutes). |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Aged 45-80 years
- Female
- Has been diagnosed with early-stage breast cancer
- Post-menopausal, defined as :
- Age ≥ 45 with no menses for at least 2 years
Key exclusion criteria (22 listed)
- Any of the following absolute contraindications to cardiopulmonary exercise testing:
- 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
- Room air desaturation at rest ≤ 85%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linear Aerobic TrainingThe 130-180 minutes/week will be achieved via either 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes per/session (± 10 minutes). | Behavioural | Linear Aerobic Training |
| Nonlinear Aerobic TrainingThe 130-180 minutes/week will be achieved via 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes/ per session (+/- 10 minutes). | Behavioural | Nonlinear Aerobic Training |
| Progressive StretchingAll sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required. | Behavioural | Progressive Stretching Group (Attention control) |
| Cardiopulmonary exercise test (CPET) | Other | Linear Aerobic Training, Nonlinear Aerobic Training, Progressive Stretching Group (Attention control) |
| Blood drawsComplete blood count | Other | Linear Aerobic Training, Nonlinear Aerobic Training, Progressive Stretching Group (Attention control) |
Primary outcome
To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.
Time frame: Baseline
VO2 or peak oxygen consumption will be measured at Baseline
To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.
Time frame: 8 weeks
VO2 or peak oxygen consumption for nonlinear aerobic training will be measured at mid-point (8 weeks)
To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.
Time frame: 16 weeks
VO2 or peak oxygen consumption will be measured at post-intervention (16 weeks).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32065769Scott JM, Thomas SM, Peppercorn JM, Herndon JE 2nd, Douglas PS, Khouri MG, Dang CT, Yu AF, Catalina D, Ciolino C, Capaci C, Michalski MG, Eves ND, Jones LW. Effects of Exercise Therapy Dosing Schedule on Impaired Cardiorespiratory Fitness in Patients With Primary Breast Cancer: A Randomized Controlled Trial. Circulation. 2020 Feb 18;141(7):560-570. doi: 10.1161/CIRCULATIONAHA.119.043483. Epub 2020 Feb 17.
- Derived from this study: PubMed 38485730Scott 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.
- Derived from this study: PubMed 35818548Michalski M, Rowed K, Lavery JA, Moskowitz CS, Capaci C, Stene G, Edvardsen E, Eves ND, Jones LW, Scott JM. Validity of Estimated Cardiorespiratory Fitness in Patients With Primary Breast Cancer. JACC CardioOncol. 2022 Jun 21;4(2):210-219. doi: 10.1016/j.jaccao.2022.05.003. eCollection 2022 Jun.
- Derived from this study: PubMed 20925920Jones LW, Douglas PS, Eves ND, Marcom PK, Kraus WE, Herndon JE 2nd, Inman BA, Allen JD, Peppercorn J. Rationale and design of the Exercise Intensity Trial (EXCITE): A randomized trial comparing the effects of moderate versus moderate to high-intensity aerobic training in women with operable breast cancer. BMC Cancer. 2010 Oct 6;10:531. doi: 10.1186/1471-2407-10-531.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Scott, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linear Aerobic Training, Nonlinear Aerobic Training and Progressive Stretching 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 23 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: finished, as of the sponsor's last update on 10 Feb 2025. 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?
Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption. (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT01186367, which also lists 4 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 Feb 2025.