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

March 8, 2024 updated by: Memorial Sloan Kettering Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: 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).
Other: Cardiopulmonary exercise test (CPET)
Other: Blood draws
Complete blood count
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.
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 as well as the CPET performed at Midpoint.
Other: Cardiopulmonary exercise test (CPET)
Other: Blood draws
Complete blood count
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 time-points

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Duke University

Investigators

  • Principal Investigator: Jessica Scott, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2010

Primary Completion (Actual)

May 17, 2023

Study Completion (Actual)

May 17, 2023

Study Registration Dates

First Submitted

August 19, 2010

First Submitted That Met QC Criteria

August 19, 2010

First Posted (Estimated)

August 23, 2010

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-147

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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