Clinical trial NCT01186367: Trial Comparing the Effects of Linear Versus Nonlinear Aerobic Training in Women With Operable Breast Cancer
Official title: Exercise Intensity Trial (EXCITE): A Randomized Trial Comparing the Effects of Linear Versus Nonlinear Aerobic Training in Women With Operable Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
Linear Versus Nonlinear Aerobic Training
15-147
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Duke University
First posted: 2010-08-23
Enrollment: 174
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* 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
* 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.

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;
  * 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

Primary outcomes:
measure: To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.
timeFrame: Baseline
measure: To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.
timeFrame: 8 weeks
measure: To Compare the Effect of High-intensity to Moderate-intensity Aerobic Training, Relative to Attention-control, on Peak Oxygen Consumption.
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jessica Scott, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Michalski 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.
citation: Jones 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.