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Clinical Trial Summary

The goal of this research study is to learn if sustained exercise can affect the outcomes in patients with a specific type of colorectal cancer called Lynch Syndrome.

This is an investigational study.

Up to 20 participants will be enrolled in this study. All will take part at MD Anderson and in the local community.


Clinical Trial Description

If you agree to take part in this study, you will be asked screening questions to complete the eligibility requirement and if you are eligible you will have the following study visits.

Study Visits:

Visit 1 (Day 0):

- You will have a lower GI endoscopy (flexible sigmoidoscopy or colonoscopy). During an endoscopy, you will be mildly sedated and a thin, flexible tube (called an endoscope) will be inserted inside the anus and rectum. Tissue samples will also be collected during this procedure. Up to 15 normal tissue biopsies will be taken during these procedures for biomarker testing, including genetic biomarkers. Biomarkers are found in the blood/tissue and may be related to the disease and the impact of exercise on the disease. If the doctor finds any abnormal tissue in your bowel during the procedure, they will be counted and removed. You will sign a separate consent for this procedure which will describe it in more detail, including its risks.

- Blood (about 1 teaspoon) and urine will be collected for biomarker testing.

- Your gums will be rubbed with a cotton swab to collect a sample of bacteria in your mouth.

- You will be asked to collect a stool sample at home either before you are prepped for your endoscopy or within 1 month (+/- 10 days) after your colonoscopy when you resume your usual bowel movements (normal bowel habits). The study staff will give you detailed instructions how to collect and then mail the stool sample. You will be given a stool collection kit and mailer in order to ship the stool sample back to the MD Anderson. If you consented over the phone and collected the stool sample before your endoscopy prep visit, the stool kit will be collected at this visit.

Visit 2 (Day 15):

- 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 bicycle at increasingly higher resistance until you reach a point that you can no longer exercise. You will be breathing into the machine while you cycle. This test will take about 30 minutes to complete. The study doctor and an exercise physiologist will be present for each CPET and available to respond to any complication.

- You will have an EKG to check your heart function.

- You will complete a questionnaire about your demographics, health history, and physical activity.

Cycling Classes and FITBIT:

Starting at Day 15 of the study, you will enroll in 3 cycling classes every week (for a total of 12 cycling classes each month). You will continue with these classes for up to 1 year. These cycling classes can be done at any fitness center in your local community. You will not be responsible for the cost of these cycling classes. You may choose any cycling class at any location you prefer.

You will be given a FITBIT to wear while you attend cycling classes. You are encouraged to wear the FITBIT during the day as well, but this is not required. The FITBIT will record your exercise frequency and intensity. The exercise physiologist will tell you how to use it, if you have any questions. The FITBIT will be yours to keep. Data from your FITBIT will be linked to your medical record.

After Day 15, you will be contacted, either phone or email, every 2 weeks by the study staff and asked about your FITBIT and FITBIT data and your exercise schedule. The exercise physiologist will discuss any barriers to exercise you may be having and/or answer any questions you may have related to physical activity, including the cycling classes.

Visit 3 (between Day 300-360):

- You will have an endoscopy as described above in Visit 1.

- Blood (about 1 teaspoon) and urine will be collected for biomarker testing.

- Your gums will be rubbed with a cotton swab to collect a sample of bacteria in your mouth.

- You will be asked to collect a stool sample at home either before you are prepped for your endoscopy or within 1 month (+/- 10 days) after your colonoscopy when you resume your usual bowel movements (normal bowel habits). The study staff will give you detailed instructions how to collect and then mail the stool sample. You will be given a stool collection kit and mailer in order to ship the stool sample back to the MD Anderson. If you consented over the phone and collected the stool sample before your endoscopy prep visit, the stool kit will be collected at this visit.

Visit 4 (within 30 days after Visit 3):

- You will have a CPET to check your heart and lung function.

- You will also complete the questionnaires about your demographics, health history, and physical activity.

Length of Study:

Your active participation in this study will be over after Visit 4. If you continue to use the FITBIT after your participation in this study is over, the data will not be viewed, collected, or entered into your medical record. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03495674
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Susan Gilchrist, MD
Phone 713-745-6251
Email sgilchrist@mdanderson.org
Status Recruiting
Phase N/A
Start date April 4, 2018
Completion date March 2021

See also
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