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 July 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: July 15, 2015
Last verified: July 2015
  Purpose

The purpose of this study is to compare the effects of 3 different types of approaches to exercise training programs 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 of the treatments used 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 adopted..


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
aerobic training will be prescribed based on the ACSM/ACS guidelines. This prescription will work toward the target of four treadmill walking sessions/week at 60%-75% of VO2peak for ~150 mins.wk-1. Treadmill walking was chosen because it is the preferred mode of exercise training for breast cancer patients.
Behavioral: Linear Aerobic Training
In the introductory phase of the program (Weeks 1-4), the frequency, duration, and intensity of aerobic training will be progressively increased from an initial prescription of 3 session/wk for ~20 mins/session at ~60-70% of VO2peak to the ultimate goal of this prescription (130 mins.wk-1 at 60%-75% VO2peak) at the end of Week 4. The goal of these sessions will be to introduce aerobic training, including warm-up, heart rate and rate of perceived exertion monitoring.
Experimental: moderate-to-high intensity
all aerobic training sessions will be performed on a motorized treadmill. The moderate-to-high intensity, non-linear aerobic training intervention will target delivery of four treadmill walking sessions/week at 60%-100% of VO2peak for ~150 mins.wk-1.
Behavioral: Non-Linear Aerobic Training
As in Arm A, all aerobic training sessions will be performed on a motorized treadmill. The moderate-to-high intensity, non-linear aerobic training intervention will target delivery of four treadmill walking sessions/week at 60%-100% of VO2peak for ~150 mins.wk-1.
Experimental: Progressive Stretching
The progressive stretching program will be prescribed according to ASCM guidelines for older adults and aimed at increasing whole-body flexibility.The ultimate goal for the progressive stretching program is 4 stretching sessions/week for 20-60 minutes/session (i.e., the same duration as aerobic training sessions).
Behavioral: Progressive Stretching
Stretching will be performed on stretching mats (i.e., no machines). Patients will be progressively trained to perform stretching exercises alternating between muscle groups/joints. Stretches will consist of prolonged holds held (under the maximum range of passive motion) initially for 20 seconds and increasing to ≥ 60 sec/stretch. Subjects in the attention-control group may continue to walk at the casual levels, but will be encouraged not to increase exercise levels in addition to the supervised program.

  Eligibility

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

Inclusion Criteria:

  • Signed informed consent prior to initiation of study-related procedures
  • Age ≥ 21 years
  • Female
  • MSKCC histologically confirmed early-stage breast cancer
  • Post-menopausal, as defined by at least one of the following:
  • Age ≥ 60
  • Aged < 60 with 12 months of natural amenorrhea (spontaneous, in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression)
  • Hysterectomy and/or bilateral oophorectomy An interval of at least one year following the 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
  • Life expectancy ≥ 6 months
  • Sedentary, as per the leisure score index (LSI) of the Godin Leisure-Time Exercise Questionnaire (GLTEQ) (Appendix B) (i.e., women not performing regular exercise on at least 5 days a week, for at least 30 minutes each session, at a moderate or vigorous intensity for the past month)
  • Exercise intolerance (i.e., patients must have a VO2peak below that predicted for sedentary age and sex-matched individuals)
  • Willing to be randomized to one of the study arms
  • Ability to read and understand English
  • Primary attending oncologist approval

Exclusion Criteria:

  • Presence of a concurrent actively treated other malignancy or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer)
  • Presence of metastatic disease;
  • Any of the following absolute or relative 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 (within 3 months) pulmonary embolus or pulmonary infarction;
    • 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.
  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: July 15, 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 August 30, 2015