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Behavioural Intervention
Exercise Therapy for Adenomatous Polyposis
N/A
Waitlist Available
Led By Samara Rifkin
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have no evidence of invasive cancer for 6 months prior to screening and must be at least 6 months from any prior cancer-directed treatment
Participants on chronic suppressive antiviral therapy for HSV are eligible
Must not have
History of total proctocolectomy
History of pelvic radiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between 4-12 weeks
Awards & highlights
No Placebo-Only Group
Summary
"This trial is looking at exercise therapy, specifically aerobic exercise therapy involving treadmill walking. The main goal is to determine the best level of exercise therapy for further testing in larger trials. The study will involve a
Who is the study for?
This trial is for individuals with familial adenomatous polyposis, a condition that causes many polyps in the intestine. Participants should be able to perform moderate-intensity exercise but specific inclusion and exclusion criteria are not detailed here.
What is being tested?
The study tests aerobic exercise therapy as a treatment, specifically treadmill walking at different intensities. It aims to find the best dose of exercise (measured in minutes per week) for future larger trials through two phases: level-finding and level-expansion.
What are the potential side effects?
Since this trial involves endurance exercise therapy, potential side effects may include muscle soreness, fatigue, joint pain or injury. However, exact side effects are not specified.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been cancer-free and haven't had cancer treatment for at least 6 months.
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I am on long-term antiviral treatment for herpes.
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I have been diagnosed with FAP, either through genetic testing or because I have had more than 50 colorectal adenomas.
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I have had surgery to remove my colon but still have my rectum.
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I haven't started taking NSAIDs like sulindac or celecoxib regularly in the last 3 months.
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I had hepatitis C but am now cured or have no detectable virus while on treatment.
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I have 5 or more rectal polyps larger than 2 mm.
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I have chronic HBV but my viral load is undetectable with treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had surgery to remove my colon and rectum.
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I have had radiation treatment to my pelvic area.
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I do not have any severe or worsening health issues other than cancer.
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My biopsy shows high-grade dysplasia or cancer.
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I do not have any severe illnesses like heart failure or mental health issues that would stop me from following the study's requirements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ between 4-12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between 4-12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Exercise therapy compliance (feasibility)
Secondary study objectives
Physiological changes
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Endurance exercise therapy comprising treadmill walkingExperimental Treatment1 Intervention
Endurance exercise therapy
Find a Location
Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
300 Previous Clinical Trials
24,333 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,969 Total Patients Enrolled
Samara RifkinPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center
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