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Trial Comparing the Effects of Linear Versus Nonlinear Aerobic Training in Women With Operable Breast Cancer (Excite)

This study is currently recruiting participants.
Verified November 2017 by Memorial Sloan Kettering Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01186367
First Posted: August 23, 2010
Last Update Posted: November 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Duke University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  Purpose
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.

Condition Intervention
Breast Cancer Behavioral: Linear Aerobic Training Behavioral: Nonlinear Aerobic Training Behavioral: Progressive Stretching Other: Cardiopulmonary exercise test (CPET) Other: Blood draws

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Exercise Intensity Trial (EXCITE): A Randomized Trial Comparing the Effects of Linear Versus Nonlinear Aerobic Training in Women With Operable Breast Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • To compare the effect of high-intensity to moderate-intensity aerobic training, relative to attention-control, on peak oxygen consumption. [ Time Frame: 3 time-points ]
    VO2 or peak oxygen consumption will be measured at 3 time-points. Baseline, mid-point (8 weeks), and post-intervention (16 weeks).


Estimated Enrollment: 174
Study Start Date: August 2010
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Linear Aerobic Training
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.
Behavioral: Linear Aerobic Training
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).
Other: Cardiopulmonary exercise test (CPET) Other: Blood draws
Complete blood count
Experimental: Nonlinear Aerobic Training
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 and as well as the CPET performed at Week 8.
Behavioral: Nonlinear Aerobic Training
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).
Other: Cardiopulmonary exercise test (CPET) Other: Blood draws
Complete blood count
Experimental: Progressive Stretching Group (Attention control)
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).
Behavioral: Progressive Stretching
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.
Other: Cardiopulmonary exercise test (CPET) Other: Blood draws
Complete blood count

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186367


Contacts
Contact: Jessica Scott, PhD 646-888-8093
Contact: Chau Dang, MD 646-888-4714

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Jessica Scott, PhD    646-888-8093      
Contact: Chau Dang, MD    646-888-4714      
Principal Investigator: Jessica Scott, PhD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Duke University
Investigators
Principal Investigator: Jessica Scott, PhD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01186367     History of Changes
Other Study ID Numbers: 15-147
First Submitted: August 19, 2010
First Posted: August 23, 2010
Last Update Posted: November 13, 2017
Last Verified: November 2017

Keywords provided by Memorial Sloan Kettering Cancer Center:
breast cancer
Linear Versus Nonlinear Aerobic Training
15-147

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases