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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Memorial Sloan Kettering Cancer Center
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01186367
First received: August 19, 2010
Last updated: December 17, 2015
Last verified: December 2015
  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: Non-Linear Aerobic Training
Behavioral: Progressive Stretching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Exercise Intensity Trial (EXCITE): A Randomized Trial Comparing the Effects of Linear Versus Non-Linear 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 ] [ Designated as safety issue: Yes ]
    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: March 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moderate-intensity Training Behavioral: Linear Aerobic Training
The ultimate goal is for participants to complete approximately 150 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 CPETs performed at baseline. The 150 minutes/week will be achieved via 4 individual aerobic training sessions at approximately 20 to 60 minutes/session.
Experimental: moderate-to-high intensity Behavioral: Non-Linear Aerobic Training
The ultimate goal is for participants to complete approximately 150 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 CPETs performed at Baseline and Week 8. The 150 minutes/week will be achieved via 4 individual aerobic training sessions at approximately 20 to 60 minutes/session.
Experimental: Progressive Stretching Behavioral: Progressive Stretching
The ultimate goal for the progressive stretching program is 4 individual stretching sessions/week for 20-60 minutes/session. 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 prescription, with dose and scheduling modifications made by exercise physiologists, as required. All adjustments will be implemented according to the standard care procedures of the exercise physiologists.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 21 years
  • Female
  • MSK histologically confirmed early-stage breast cancer
  • Post-menopausal, defined as :
  • Age ≥ 60 or
  • Age < 60 with 12 months of natural amenorrhea (spontaneous, in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) or
  • Hysterectomy and/or bilateral oophorectomy An interval of at least one year, but no more than five years, following the full completion of primary therapy (i.e., completion of definitive surgery plus chemotherapy, radiation, and trastuzumab)
  • An interval of no longer than five years following completion of primary therapy. Primary therapy is defined as:
  • Surgery plus radiation
  • Surgery plus chemotherapy
  • Surgery plus trastuzumab 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.
  • BMI < 40
  • ECOG ≤ 1
  • Life expectancy ≥ 6 months
  • Sedentary, as per the leisure score index (LSI) of the Godin Leisure-Time Exercise Questionnaire (GLTEQ) (Appendix B) Participants who perform regular moderate or vigorous intensity exercise at least 5 days/week, for at least 30 minutes/session, are not eligible.
  • 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
  • Medical clearance from attending physician to undergo a symptom-limited CPET and aerobic training intervention
  • Able to complete an acceptable baseline CPET, as determined by the absence of remarkable ECG findings or other inappropriate response to exercise.
  • 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:

  • 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 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;
    • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186367

Contacts
Contact: Lee W Jones, PhD 646.888.8102
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: Lee Jones, PhD    646-888-8102      
Contact: Chau Dang, MD    646-888-4714      
Principal Investigator: Lee Jones, PhD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Duke University
Investigators
Principal Investigator: Lee W Jones, PhD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
No publications provided by Memorial Sloan Kettering Cancer Center

Additional 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 
Study First Received: August 19, 2010
Last Updated: December 17, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan Kettering Cancer Center:
breast cancer

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

ClinicalTrials.gov processed this record on February 04, 2016