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



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - 80
Updated:8/4/2018
Start Date:August 2010
End Date:January 2019

Use our guide to learn which trials are right for you!

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.


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
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Jessica Scott, PhD
Phone: 646-888-8093
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
?
mi
from
New York, NY
Click here to add this to my saved trials