High-Frequency Microsatellite InstabilityNCT03495674
Cycling in Preventing Colorectal Cancer in Participants With Lynch Syndrome
A study testing Exercise Intervention, Informational Intervention and Monitoring Device in people with High-Frequency Microsatellite Instability and Mismatch Repair Gene Mutation, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies how well cycling works in preventing colorectal cancer in participants with Lynch syndrome. Exercise such as cycling may reduce colorectal cancer risk in participants with Lynch syndrome. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- High-Frequency Microsatellite Instability, Mismatch Repair Gene Mutation, Mutation-Negative Lynch Syndrome
- What is being tested?
- Exercise Intervention, Informational Intervention and Monitoring Device
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2018to 2 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must have Lynch syndrome defined as meeting any of the following: (1) Mutation-positive Lynch syndrome: carriers or obligate carriers (by pedigree) of a pathogenic mutation in one of the deoxyribonucleic acid (DNA) mismatch repair (MMR) genes (i.e. MLH1, MSH2/EPCAM, MSH6, or PMS2) or (2) Mutation-negative Lynch syndrome: patients with a personal history of a non-sporadic MMR deficient premalignant lesion (i.e. polyp) or a non sporadic MMR deficient malignant tumor (where non-sporadic MMR deficient is defined by: microsatellite instability high by either immunohistochemistry or microsatellite instability (MSI) testing or both, but no evidence of MLH1 promoter methylation in cases with loss of both MLH1 and PMS2, and/or no evidence of BRAF mutation in cases with loss of both MLH1 and PMS2) but germline MMR genetic testing showed either a variant of unknown significance or mutation negative result or had declined germline MMR genetic testing.
- Participants must not have evidence of active/recurrent malignant disease for a minimum of 6 months.
- Participants must be at least 6 months from any prior cancer-directed treatment (such as surgical resection, chemotherapy, immunotherapy, hormonal therapy or radiation).
- Participants must have endoscopically accessible distal colon and/or rectal mucosa (i.e. participants must have at least part of the descending/sigmoid colon and/or rectum intact).
- Participants must consent to two standard of care lower gastro-intestinal GI endoscopy (flexible sigmoidoscopy or colonoscopy) with biopsies that will be 12 months (+/-21 days) apart.
- Ability to understand and the willingness to sign a written informed consent document.
- Must have normal cardiopulmonary exercise test prior to exercise participation.
Who cannot join
- Individuals who are status post total proctocolectomy (i.e. removal of all colon and rectum).
- Individuals with history of myocardial infarction, stroke, coronary-artery bypass draft, invasive coronary revascularization, arrhythmia requiring treatment such as atrial fibrillation, congestive heart failure, peripheral vascular disease, pulmonary embolism, or deep venous thrombosis.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Individuals with a history of diabetes, hypertension, or have smoked cigarettes in the last 12 months.
- Individuals who are unable to participate in cycling due to musculoskeletal limitations.
- Individuals who are unable to identify cycling classes in their community for exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CYCling Lynch Patients for Exercise and Prevention: CYCLE-P
This trial studies how well cycling works in preventing colorectal cancer in participants with Lynch syndrome. Exercise such as cycling may reduce colorectal cancer risk in participants with Lynch syndrome.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the feasibility of a 12-month exercise cycling intervention among Lynch syndrome (LS) patients.
SECONDARY OBJECTIVES:
- To assess the effect size of exercise on circulating biomarkers as well as regulation of genomic, transcriptomic, and immunologic biomarkers in normal intestinal mucosa of LS patients.
OUTLINE: Participants are assigned to 1 of 2 groups.
GROUP I: Starting on day 15, participants wear FITBIT and complete cycling classes over 45 minutes 3 times a week for a total of 12 classes a month for up to 1 year.
GROUP II: Starting on day 15, participants receive information about exercise guidelines and wear FITBIT to track heart rate and activities for up to 1 year.
After completion of study interventions, participants are followed up at 30 days.
- Conditions
- High-Frequency Microsatellite Instability, Mismatch Repair Gene Mutation, Mutation-Negative Lynch Syndrome, Mutation-Positive Lynch Syndrome
- Being tested
- Exercise Intervention, Informational Intervention, Monitoring Device, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
Complete cycling classes
Informational InterventionOther
Receive information about exercise guidelines
Monitoring DeviceDevice
Also called Monitor
Wear Fitbit
Questionnaire AdministrationOther
Complete questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Group I (FITBIT, cycling) | Experimental | Starting on day 15, participants wear FITBIT and complete cycling classes over 45 minutes 3 times a week for a total of 12 classes a month for up to 1 year. Receives: Behavioral: Exercise Intervention; Device: Monitoring Device; Other: Questionnaire Administration |
| Group II (FITBIT, information) | Active comparator | Starting on day 15, participants receive information about exercise guidelines and wear FITBIT to track heart rate and activities for up to 1 year. Receives: Other: Informational Intervention; Device: Monitoring Device; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Defined as the proportion of eligible patients who consent to the number of patients who are contacted. This study will be considered as feasible if the recruitment rate is at least 20%.
Measured: Up to 1 year
Adherence rate
Defined as the proportion of the actual attendance number to the planned number of exercise sessions (12 sessions monthly x 12 months) where patients will be required to comply with duration (time) of each session participated as well as monthly attendance. This study will be considered as feasible if the adherence rate is at least 75%.
Measured: Up to 1 year
Retention
Defined as the proportion of participants who stay until study completion. This study will be considered as feasible if the retention rate is at least 75%.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start4 Apr 2018
- Primary completion2 Jan 2024
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Frequency Microsatellite InstabilityStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Eduardo Vilar-Sanchez, BLS,MD,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495674
- Sponsor's protocol ID
- 2017-1035
- Other IDs
- NCI-2018-01046, 2017-1035
- Status last verified
- Jan 2024
- First submitted
- 4 Apr 2018
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CYCling Lynch Patients for Exercise and Prevention: CYCLE-P
- ClinicalTrials.gov ID
- NCT03495674
- Acronym / sponsor ID
- 2017-1035
- Conditions
- High-Frequency Microsatellite Instability, Mismatch Repair Gene Mutation, Mutation-Negative Lynch Syndrome, Mutation-Positive Lynch Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial studies how well cycling works in preventing colorectal cancer in participants with Lynch syndrome. Exercise such as cycling may reduce colorectal cancer risk in participants with Lynch syndrome.
Detailed description
PRIMARY OBJECTIVES:
- To assess the feasibility of a 12-month exercise cycling intervention among Lynch syndrome (LS) patients.
SECONDARY OBJECTIVES:
- To assess the effect size of exercise on circulating biomarkers as well as regulation of genomic, transcriptomic, and immunologic biomarkers in normal intestinal mucosa of LS patients.
OUTLINE: Participants are assigned to 1 of 2 groups.
GROUP I: Starting on day 15, participants wear FITBIT and complete cycling classes over 45 minutes 3 times a week for a total of 12 classes a month for up to 1 year.
GROUP II: Starting on day 15, participants receive information about exercise guidelines and wear FITBIT to track heart rate and activities for up to 1 year.
After completion of study interventions, participants are followed up at 30 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (FITBIT, cycling) | Experimental | Behavioral: Exercise Intervention, Device: Monitoring Device, Other: Questionnaire AdministrationStarting on day 15, participants wear FITBIT and complete cycling classes over 45 minutes 3 times a week for a total of 12 classes a month for up to 1 year. |
| Group II (FITBIT, information) | Active comparator | Other: Informational Intervention, Device: Monitoring Device, Other: Questionnaire AdministrationStarting on day 15, participants receive information about exercise guidelines and wear FITBIT to track heart rate and activities for up to 1 year. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants must have Lynch syndrome defined as meeting any of the following: (1) Mutation-positive Lynch syndrome: carriers or obligate carriers (by pedigree) of a pathogenic mutation in one of the deoxyribonucleic acid (DNA) mismatch repair (MMR) genes (i.e. MLH1, MSH2/EPCAM, MSH6, or PMS2) or (2) Mutation-negative Lynch syndrome: patients with a personal history of a non-sporadic MMR deficient premalignant lesion (i.e. polyp) or a non sporadic MMR deficient malignant tumor (where non-sporadic MMR deficient is defined by: microsatellite instability high by either immunohistochemistry or microsatellite instability (MSI) testing or both, but no evidence of MLH1 promoter methylation in cases with loss of both MLH1 and PMS2, and/or no evidence of BRAF mutation in cases with loss of both MLH1 and PMS2) but germline MMR genetic testing showed either a variant of unknown significance or mutation negative result or had declined germline MMR genetic testing.
- Participants must not have evidence of active/recurrent malignant disease for a minimum of 6 months.
- Participants must be at least 6 months from any prior cancer-directed treatment (such as surgical resection, chemotherapy, immunotherapy, hormonal therapy or radiation).
- Participants must have endoscopically accessible distal colon and/or rectal mucosa (i.e. participants must have at least part of the descending/sigmoid colon and/or rectum intact).
- Participants must consent to two standard of care lower gastro-intestinal GI endoscopy (flexible sigmoidoscopy or colonoscopy) with biopsies that will be 12 months (+/-21 days) apart.
Key exclusion criteria (6 listed)
- Individuals who are status post total proctocolectomy (i.e. removal of all colon and rectum).
- Individuals with history of myocardial infarction, stroke, coronary-artery bypass draft, invasive coronary revascularization, arrhythmia requiring treatment such as atrial fibrillation, congestive heart failure, peripheral vascular disease, pulmonary embolism, or deep venous thrombosis.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Individuals with a history of diabetes, hypertension, or have smoked cigarettes in the last 12 months.
- Individuals who are unable to participate in cycling due to musculoskeletal limitations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionComplete cycling classes | Behavioural | Group I (FITBIT, cycling) |
| Informational InterventionReceive information about exercise guidelines | Other | Group II (FITBIT, information) |
| Monitoring DeviceAlso: MonitorWear Fitbit | Device | Group I (FITBIT, cycling), Group II (FITBIT, information) |
| Questionnaire AdministrationComplete questionnaire | Other | Group I (FITBIT, cycling), Group II (FITBIT, information) |
Primary outcome
Recruitment rate
Time frame: Up to 1 year
Defined as the proportion of eligible patients who consent to the number of patients who are contacted. This study will be considered as feasible if the recruitment rate is at least 20%.
Adherence rate
Time frame: Up to 1 year
Defined as the proportion of the actual attendance number to the planned number of exercise sessions (12 sessions monthly x 12 months) where patients will be required to comply with duration (time) of each session participated as well as monthly attendance. This study will be considered as feasible if the adherence rate is at least 75%.
Retention
Time frame: Up to 1 year
Defined as the proportion of participants who stay until study completion. This study will be considered as feasible if the retention rate is at least 75%.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Vilar-Sanchez, BLS,MD,PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention, Informational Intervention and Monitoring Device in people with High-Frequency Microsatellite Instability and Mismatch Repair Gene Mutation, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Up to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.