Exercise Therapy for Adenomatous Polyposis

Not yet recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan Rogel Cancer Center

Must not be taking: NSAIDs, Weight loss medications

Disqualifiers: Total proctocolectomy, Cancer, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the ideal amount of exercise for managing familial adenomatous polyposis (FAP), a condition that causes multiple polyps in the colon and rectum. Participants will engage in supervised treadmill walking as part of endurance exercise therapy to determine the optimal exercise level for future studies. The trial seeks individuals with FAP who have more than 50 colorectal adenomas and currently exercise less than 60 minutes per week. The aim is to assess whether exercise can aid in managing FAP.

As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could enhance FAP management through exercise.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot start taking certain medications like NSAIDs or weight loss drugs within 3 months before the trial or during it.

What prior data suggests that this exercise therapy is safe?

Research shows that exercise, such as walking on a treadmill, is generally safe. Although specific safety information for individuals with adenomatous polyposis is lacking, exercise has been studied for its health benefits. Studies indicate that regular exercise can reduce the risk of colorectal cancer and lower the number of polyps, suggesting it is usually well-tolerated. While this trial aims to determine the optimal amount of exercise for future studies, past research supports exercise as a safe option for many people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for adenomatous polyposis, which often involve surgery or medication to manage polyp growth, endurance exercise therapy offers a non-invasive alternative. This approach focuses on treadmill walking to potentially influence the body's natural processes, which could reduce or manage polyps without the need for more aggressive interventions. Researchers are excited because exercise therapy might harness the body's own mechanisms to achieve results, offering a safer and potentially more accessible option for patients.

What evidence suggests that exercise therapy is effective for adenomatous polyposis?

Research has shown that physical fitness, improved through regular exercise, might help prevent colorectal cancer. Studies have found that exercise can reduce the total number of intestinal growths, called polyps, by half and decrease the number of larger polyps by 67%. Clinical trials and reviews of multiple studies consistently demonstrate that exercise effectively lowers the risk of colorectal cancer. This trial will specifically evaluate endurance exercise therapy, such as treadmill walking, as a promising method to manage conditions like adenomatous polyposis. ^{1 2 4 6 7}

Who Is on the Research Team?

Samara Rifkin

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Inactive defined as ≤ 60 minutes of moderate or strenuous exercise per week over the past month

No self-reported contraindications to regular exercise as evaluated by the PAR-Q+

I am on long-term antiviral treatment for herpes.

Exclusion Criteria

Pregnant women

I have had surgery to remove my colon and rectum.

Participants receiving any other investigational agents

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a Level-finding

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

4-12 weeks

Phase 1b Level-expansion

Further evaluation of the highest feasible level and one level below identified in the phase 1a study

4-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Endurance Exercise Therapy

Trial Overview

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.

How Is the Trial Designed?

Group I: Endurance exercise therapy comprising treadmill walking Experimental Treatment 1 Intervention

Endurance exercise therapy

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Regular physical activity can significantly reduce the risk of several types of cancer, including colon, endometrial, and postmenopausal breast cancer, with relative risk reductions ranging from 10-30%.

Exercise is not only beneficial for cancer prevention but is also safe and effective in managing symptoms related to cancer and its treatment, improving quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of physical activity on cancer risk and disease progression after cancer diagnosis]. Steindorf, K., Schmidt, M., Ulrich, C.[2018]

A review of 19 cohort studies found that physically active males have a significantly reduced risk of colon cancer, with risk ratios of 0.79 for occupational activities and 0.78 for recreational activities.

For women, only recreational physical activities were associated with a protective effect against colon cancer (RR = 0.71), while no significant protection was observed for rectal cancer in either sex.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of the association of physical activity with reduced risk of colorectal cancer. Samad, AK., Taylor, RS., Marshall, T., et al.[2006]

Physical inactivity is linked to 13-14% of colon cancer cases, suggesting that being active may be more important than family history in reducing risk.

While there is some evidence that physical activity can improve outcomes after a colorectal cancer diagnosis, the specific effects of exercise interventions on cancer risk and prognosis remain unclear, and no optimal exercise regimen has been established.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity before and after diagnosis of colorectal cancer: disease risk, clinical outcomes, response pathways and biomarkers. Harriss, DJ., Cable, NT., George, K., et al.[2021]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06641310?cond=%22Familial%20Adenomatous%20Polyposis%22&viewType=Table&rank=6

Trial of Exercise Therapy in Familial Adenomatous Polyp ...

The form of exercise therapy will be aerobic exercise therapy comprised of supervised moderate-intensity treadmill walking. The primary objective of this study ...

2.

withpower.com

withpower.com/trial/phase-adenomatous-polyps-9-2024-989af

Exercise Therapy for Adenomatous Polyposis

Research suggests that good physical fitness, which can be improved through endurance exercise, may help prevent the development of colorectal cancer in ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10648074/

Exercise as a Promising Agent against Cancer

Additionally, exercise has been found to decrease the whole number of intestinal polyps by 50% and the number of large polyps by 67% [73]. Both ...

4.

cancerci.biomedcentral.com

cancerci.biomedcentral.com/articles/10.1186/s12935-022-02670-3

Exercise and colorectal cancer: prevention and molecular ...

A huge number of clinical trials and meta-analysis have demonstrated that exercise is significantly effective in lowering the risk of colorectal cancer.

5.

ctv.veeva.com

ctv.veeva.com/study/trial-of-exercise-therapy-in-familial-adenomatous-polyp-fap

Trial of Exercise Therapy in Familial Adenomatous Polyp (FAP)

The primary objective of this study is to identify the most appropriate level (the recommended phase 2 dose; RP2D) of exercise therapy for ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8535689/

Prevalence of Colorectal Polyps Based on ...

For physical activity, it was reported that the incidence of colorectal polyps decreased by 10% in individuals who exercised for more than 3 h ...

7.

oss.jomh.org

oss.jomh.org/files/article/20201210-67/pdf/139-Article%20Text-1142-2-10-20190809.pdf

THE RELATIONSHIP BETWEEN EXERCISE, ...

Higher cardiopulmonary fitness, along with increased exercise frequency, intensity, and duration, could lower the prevalence of polyps in younger and middle- ...