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Trial record 79 of 482 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

Tracking Information
First Submitted Date  ICMJE April 4, 2018
First Posted Date  ICMJE April 12, 2018
Last Update Posted Date August 15, 2019
Actual Study Start Date  ICMJE April 4, 2018
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • 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%.
Original Primary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
Feasibility of a 12-Month Exercise Cycling Intervention Among Lynch Syndrome Patients Feasibility will be evaluated with recruitment (in terms of eligibility and consent), retention and adherence rates. [ Time Frame: Baseline up to 390 days ]
Feasibility evaluated with recruitment (in terms of eligibility and consent), retention and adherence rates. Study considered as feasible if the recruitment rate is at least 20%, along with at least 75% for both adherence and retention rates.
Change History Complete list of historical versions of study NCT03495674 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cycling in Preventing Colorectal Cancer in Participants With Lynch Syndrome
Official Title  ICMJE CYCling Lynch Patients for Exercise and Prevention: CYCLE-P
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • High-Frequency Microsatellite Instability
  • Mismatch Repair Gene Mutation
  • Mutation-Negative Lynch Syndrome
  • Mutation-Positive Lynch Syndrome
Intervention  ICMJE
  • Behavioral: Exercise Intervention
    Complete cycling classes
  • Other: Informational Intervention
    Receive information about exercise guidelines
  • Device: Monitoring Device
    Wear Fitbit
    Other Name: Monitor
  • Other: Questionnaire Administration
    Complete questionnaire
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Exercise Intervention
    • Device: Monitoring Device
    • Other: Questionnaire Administration
  • 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.
    Interventions:
    • Other: Informational Intervention
    • Device: Monitoring Device
    • Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 13, 2019)
21
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2018)
20
Estimated Study Completion Date  ICMJE March 31, 2021
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03495674
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Susan C Gilchrist M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP