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Trial record 79 of 480 for:    colon cancer | ( Map: Texas, United States )

Cycling in Preventing Colorectal Cancer in Participants With Lynch Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495674
Recruitment Status : Active, not recruiting
First Posted : April 12, 2018
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
High-Frequency Microsatellite Instability Mismatch Repair Gene Mutation Mutation-Negative Lynch Syndrome Mutation-Positive Lynch Syndrome Behavioral: Exercise Intervention Other: Informational Intervention Device: Monitoring Device Other: Questionnaire Administration Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess the feasibility of a 12-month exercise cycling intervention among Lynch syndrome (LS) patients.

SECONDARY OBJECTIVES:

I. 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: CYCling Lynch Patients for Exercise and Prevention: CYCLE-P
Actual Study Start Date : April 4, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group I (FITBIT, cycling)
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.
Behavioral: Exercise Intervention
Complete cycling classes

Device: Monitoring Device
Wear Fitbit
Other Name: Monitor

Other: Questionnaire Administration
Complete questionnaire

Active Comparator: Group II (FITBIT, information)
Starting on day 15, participants receive information about exercise guidelines and wear FITBIT to track heart rate and activities for up to 1 year.
Other: Informational Intervention
Receive information about exercise guidelines

Device: Monitoring Device
Wear Fitbit
Other Name: Monitor

Other: Questionnaire Administration
Complete questionnaire




Primary Outcome Measures :
  1. 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%.

  2. 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%.

  3. 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%.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495674


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Susan C Gilchrist M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03495674     History of Changes
Other Study ID Numbers: 2017-1035
NCI-2018-01046 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2017-1035 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms, Hereditary Nonpolyposis
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Neoplastic Syndromes, Hereditary
Colonic Diseases
Syndrome
Microsatellite Instability
Disease
Pathologic Processes
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases
Genomic Instability