Trial Title:
Trial of Exercise Therapy in Familial Adenomatous Polyp (FAP)
NCT ID:
NCT06641310
Condition:
Familial Adenomatous Polyposis
Conditions: Official terms:
Adenomatous Polyposis Coli
Adenomatous Polyps
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Endurance Exercise Therapy
Description:
- Exercise: Endurance exercise therapy comprising treadmill walking administered by
exercise physiologists via a study-kit which includes a smart-watch (activity
tracker), heart rate monitor, blood pressure cuff, body composition scale, and
etablet)
- Exercise escalation trial testing 3 exercise levels (150, 225, and 300 minutes per
week), with one de-escalation exercise of 90 minutes per week, if required.
- The phase 1b trial will evaluate the highest feasible exercise level and one
exercise below identified in the phase 1a study.
Arm group label:
Endurance exercise therapy comprising treadmill walking
Summary:
The study intervention being investigated in this phase 1a/b trial is exercise therapy.
The form of exercise therapy will be aerobic exercise therapy comprised of supervised
moderate-intensity treadmill walking.
The primary objective of this study is to identify the most appropriate level (the
recommended phase 2 dose; RP2D) of exercise therapy for investigation in larger trials.
To identify the RP2D of exercise therapy we will conduct a phase 1a level-finding trial
and a phase 1b level-expansion trial. The phase 1a study is a level escalation trial
evaluating 3 exercise levels (150, 225, and 300 minutes per week), with one de-escalation
level of 90 minutes per week, if required. The phase 1b trial will further evaluate the
highest feasible level and one LEVEL below identified in the phase 1a study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Individuals with FAP as defined by:
- Genetic diagnosis: APC germline mutation (with or without FAP family history),
OR
- Clinical diagnosis: FAP phenotype with a history of more than 50 colorectal
adenomas
- Have an intact rectum defined as status post colectomy and ileocolonic anastomosis
for polyposis or pre-colectomy
- ≥ 5 rectal polyps > 2 mm in size on baseline lower endoscopy
- 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
(such as surgical resection, chemotherapy, immunotherapy, hormonal therapy or
radiation)
- No initiation of daily use of sulindac, celecoxib or other non-steroidal
anti-inflammatory medications (NSAIDs) within 3 months of day 1 and no initiation >
25% of the time (> 8 days/month) for the duration of study participation
- No initiation of semaglutide, liraglutide (glucagon-like peptide-1 receptor agonist
[GLP-1 receptor agonist]), tirzepatide (glucose-dependent insulinotropic polypeptide
[GIP]), orlistat (lipase inhibitor) or other weight loss medications, within 3
months of day 1 and during study participation
- Adults ≥ 18 years of age
- Human immunodeficiency virus (HIV)-infected participants on effective
anti-retroviral therapy with undetectable viral load within 6 months are eligible
for this trial
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV
viral load must be undetectable on suppressive therapy, if indicated
- Participants with a history of hepatitis C virus (HCV) infection must have been
treated and cured. For participants with HCV infection who are currently on
treatment, they are eligible if they have an undetectable HCV viral load
- Participants on chronic suppressive antiviral therapy for herpes simplex virus (HSV)
are eligible
- Lower endoscopy, required for participation in the study, is contraindicated in
pregnancy. Women of child-bearing potential must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) for the duration of study
participation, and until after the end of study endoscopy is completed. Should a
woman become pregnant or suspect she is pregnant while participating in this study,
she should inform the study team immediately
- Inactive defined as ≤ 60 minutes of moderate or strenuous exercise per week over the
past month as assessed by the Godin Leisure Time Exercise Questionnaire
- No self-reported contraindications to regular exercise as evaluated by the Physical
Activity Readiness Questionnaire (PAR-Q+)
- Sufficient space to house a treadmill in primary residence for the intervention
period or access to an approved treadmill (as determined by study exercise
physiologist) for the intervention period (e.g., participant may have access to a
treadmill via an existing membership to a health club)
- Ability for study team to deliver and install exercise equipment in primary
residence
- Note: If participant will be using treadmill from another source approved by
study exercise physiologist, this inclusion criteria is not applicable
- Internet or Wi-Fi connection. For participants without internet or Wi-Fi, a pre-paid
cellular iPad will be provided
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests, and other study procedures
- Physician approval
- Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria:
- History of total proctocolectomy
- Histologically-confirmed high-grade dysplasia or cancer on biopsy at screening
- History of pelvic radiation
- Participants receiving any other investigational agents
- Uncontrolled intercurrent illness including, but not limited to, symptomatic
congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or
psychiatric illness/social situations that would limit compliance with study
requirements
- History of severe, progressive, or uncontrolled renal, genitourinary, hepatic,
hematologic, endocrine, cardiac, vascular, pulmonary, rheumatologic, neurologic,
psychiatric, or metabolic disturbances, or signs and symptoms thereof
- Pregnant women are excluded since endoscopy is not recommended while pregnant
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Michigan Rogel Cancer Center
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Contact:
Last name:
Kirsten Tuck
Phone:
734-763-1141
Email:
KLtuck@med.umich.edu
Investigator:
Last name:
Samara Rifkin
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Contact:
Last name:
Catherine Lee
Phone:
646-888-8097
Email:
leec10@mskcc.org
Investigator:
Last name:
Arnold Markowitz
Email:
Principal Investigator
Facility:
Name:
Cleveland Clinic Foundation
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Contact:
Last name:
Rashad Spruill
Phone:
216-444-1815
Email:
SPRUILR@ccf.org
Investigator:
Last name:
Carol A. Burke
Email:
Principal Investigator
Start date:
October 31, 2024
Completion date:
October 31, 2026
Lead sponsor:
Agency:
University of Michigan Rogel Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Michigan Rogel Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06641310
