Cardiac Rehabilitation Program in Improving Cardiorespiratory Fitness in Stage 0-III Breast Cancer Survivors
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 30 - 75 |
| Updated: | 1/10/2018 |
| Start Date: | May 14, 2015 |
| End Date: | September 30, 2018 |
| Contact: | The Ohio State University Comprehensive Cancer Center |
| Email: | Osucccclinicaltrials@osumc.edu |
A Cardiac Rehabilitation Program for Breast Cancer Survivors: A Feasibility Study
This clinical trial studies a cardiac rehabilitation program in improving cardiorespiratory
fitness in stage 0-III breast cancer survivors. Cardiovascular disease is the leading cause
of death of women in both the general population and the breast cancer survivor population.
There are many risk factors common to both heart disease and breast cancer development,
including physical inactivity. A cardiac rehabilitation program may help improve
cardiorespiratory fitness, reduce cardiovascular disease risk factors, and improve quality of
life among breast cancer survivors.
fitness in stage 0-III breast cancer survivors. Cardiovascular disease is the leading cause
of death of women in both the general population and the breast cancer survivor population.
There are many risk factors common to both heart disease and breast cancer development,
including physical inactivity. A cardiac rehabilitation program may help improve
cardiorespiratory fitness, reduce cardiovascular disease risk factors, and improve quality of
life among breast cancer survivors.
PRIMARY OBJECTIVES:
I. Assess the feasibility of conducting a 14-week cardiac rehabilitation (CR) program in
women with breast cancer after completion of acute therapy.
II. Preliminarily evaluate the efficacy of CR in improving cardiorespiratory fitness (peak
oxygen uptake, maximum volume of oxygen [VO2 max]) at baseline and 14 weeks.
III. Explore changes in cardiovascular disease (CVD) risk factors (blood pressure,
cholesterol, fasting glucose, and body mass index) between baseline and 14-week follow-up.
Blood pressure and body mass index will also be checked at 8 weeks.
IV. Quantify the difference in quality of life (QoL) between baseline, 8 week, and 14 week
follow up, adjusting for baseline QoL values.
OUTLINE:
Patients participate in a CR program consisting of 1-hour CR intervention sessions, based on
a personalized exercise prescription, 3 times per week for 14 weeks (a total of 36 sessions).
Components of the exercise prescription includes intensity, mode, duration, and frequency.
Intensity of exercise is guided by the results of a graded exercise stress test, rating of
perceived exertion (RPE), heart rate, and symptoms, such as chest pain/angina or shortness of
breath. If exercise is well-tolerated during CR sessions, patients are encouraged to
supplement their exercise program at home, increasing their exercise frequency to up to 5
times per week. Patients may attend weekly educational sessions offered by the Phase 2 CR
program which covers topics such as stress management, smoking cessation, nutrition, and
weight loss.
I. Assess the feasibility of conducting a 14-week cardiac rehabilitation (CR) program in
women with breast cancer after completion of acute therapy.
II. Preliminarily evaluate the efficacy of CR in improving cardiorespiratory fitness (peak
oxygen uptake, maximum volume of oxygen [VO2 max]) at baseline and 14 weeks.
III. Explore changes in cardiovascular disease (CVD) risk factors (blood pressure,
cholesterol, fasting glucose, and body mass index) between baseline and 14-week follow-up.
Blood pressure and body mass index will also be checked at 8 weeks.
IV. Quantify the difference in quality of life (QoL) between baseline, 8 week, and 14 week
follow up, adjusting for baseline QoL values.
OUTLINE:
Patients participate in a CR program consisting of 1-hour CR intervention sessions, based on
a personalized exercise prescription, 3 times per week for 14 weeks (a total of 36 sessions).
Components of the exercise prescription includes intensity, mode, duration, and frequency.
Intensity of exercise is guided by the results of a graded exercise stress test, rating of
perceived exertion (RPE), heart rate, and symptoms, such as chest pain/angina or shortness of
breath. If exercise is well-tolerated during CR sessions, patients are encouraged to
supplement their exercise program at home, increasing their exercise frequency to up to 5
times per week. Patients may attend weekly educational sessions offered by the Phase 2 CR
program which covers topics such as stress management, smoking cessation, nutrition, and
weight loss.
Inclusion Criteria:
- Diagnosed with breast cancer stages 0-III within 6 months after completion of all
planned surgery, radiation and or chemotherapy treatments
- Concurrent endocrine therapy permissible
- Ability to understand and the willingness to sign a written informed consent
- Willingness to participate in CR program
Exclusion Criteria:
- Existing CVD
- Existing diabetes
- Contraindications to exercise
- Metastatic breast cancer
- Other concurrent malignancies except skin cancer
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, or psychiatric illness/social situation that would limit compliance with
study requirements
- Pregnant or nursing women
- Unable to give informed consent
- Any contraindication to cardiac stress testing
- Travel distance greater than 50 miles
We found this trial at
1
site
Columbus, Ohio 43210
Principal Investigator: Maryam Lustberg, MD
Phone: 614-293-8858
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