Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02923401 |
| Other study ID # |
2016-0442 |
| Secondary ID |
NCI-2016-01938 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 30, 2016 |
| Est. completion date |
January 5, 2022 |
Study information
| Verified date |
February 2022 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this research study is to learn if there is a level of exercise training that is
more effective in lowering biomarker levels that are linked to breast cancer risk. Biomarkers
are found in the blood/tissue and may be related to your reaction to exercise.
This is an investigational study. Up to 72 participants will be enrolled in this study. All
will take part at MD Anderson.
Description:
Study Groups:
If you agree to take part in this research study, you will be randomly assigned (as in a roll
of dice) to 1 of 3 study groups. This is done because no one knows if one study group is
better, the same, or worse than the other group. You will have an equal chance of being
assigned to each group:
- If you are in Group 1, you will take part in high-intensity interval (HIIT) exercise.
- If you are in Group 2, you will take part in moderate-intensity exercise.
- If you are in Group 3, you will not take part in any assigned exercise, but you will
receive written materials and counseling by an exercise physiologist.
If you are in Group 1 or Group 2, you will also receive written materials and instructions on
how to perform your exercises.
Physical Activity:
If you are in Group 1 or 2, you will come to the Energy Balance Center to exercise 3 times a
week for 12 weeks.
If you are in Group 1, you will walk uphill on a treadmill for a total of 33 minutes. There
will be a 5-minute warm up, followed by four 4-minute intervals. Between each interval, you
will walk for 3 minutes. There will be a 3 minute cool down.
If you are in Group 2, you will exercise at the Energy Balance Center 3 times a week. You
will walk uphill on a treadmill or use a stationary bicycle continuously for 41 minutes.
If you are in Group 3, 1 time each month while you are on study, you will be called by a
member of the study staff and asked about any exercise you have done and your weight loss
goals. Each phone call should take about 15 minutes.
The exercise training intensity may be reduced or stopped temporarily if you experience side
effects.
Length of Study:
No matter which group you are in, your participation in this study will be over after 12
weeks. You will be taken off study if you have intolerable side effects.
Study Visits:
All participants will visit the MD Anderson Behavioral Research and Treatment Center for each
study visit.
At baseline:
- You will have a cardiopulmonary exercise test (CPET) to check your lung function. The
CPET checks how well your lungs are working by measuring how much oxygen and carbon
dioxide your lungs take in and release when you breathe. To perform this test, you will
be asked to walk on a treadmill until you reach a point that you can no longer exercise.
You will be breathing into the machine while you walk. This test will take about 30
minutes to complete. The study doctor will be present for each CPET and available to
respond to any complication.
- You will have an EKG to check your heart function. The study doctor will be present for
each EKG you have.
- Blood (about 1½ tablespoons) will be drawn for biomarker testing. You will be asked to
fast (eat nothing and drink only water) for at least 12 hours before each blood draw as
part of this study.
- You will have a dual-energy x-ray absorptiometry (DEXA) scan to measure your body mass.
- You will complete a questionnaire that will ask you about your demographics (age, race,
and so on), past medical history, and lifestyle habits. This questionnaire should take
about 5 minutes to complete.
- You will complete 5 questionnaires about your quality of life, exercise experience, and
level of fatigue. These should take a total of about 15 minutes to complete.
At 6 weeks:
- You will have a CPET.
- You will have an EKG.
At 12 weeks:
- You will have a CPET.
- Blood (about 1½ tablespoons) will be drawn for biomarker testing.
- You will have an EKG.
- You will have a DEXA scan.
- You will complete the same questionnaires that you completed at baseline.
- If you are in Group 1 or 2, you will be interviewed by a member of the study staff. You
will be asked 5 questions about your experience with your assigned exercise program. It
should take about 5 minutes to complete.
One (1) time each month, you will attend a motivational session. During this session, you
will discuss strategies for overcoming barriers that may be keeping you from attending or
completing your exercises. You will also talk about continuing physical activity after you
complete the program. This session should last about 15-30 minutes.
Additional Information:
- Trained health professionals will be present at all study visits to address any symptoms
during exercise. If you feel that you are having difficulty breathing, experiencing
dizziness, or are having any heart related symptoms while exercising at home, please
stop exercising and call 911 immediately.
- Clinical information such as your name, patient medical record number, age, gender, body
mass index (BMI), zip code, and your complete medical history will be collected from
your medical record.
- If you are in Group 1 or Group 2, you will receive text messages before each exercise
session to remind you to attend. You will be responsible for any text messaging charges.
Standard text message rates will apply.
