Exercise Therapy for Adenomatous Polyposis

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

32 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Endurance 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 patients with familial adenomatous polyposis (FAP). A study found that patients with higher physical fitness levels had a lower risk of colorectal cancer and smaller polyp sizes. ^{1 2 3 4 5}

Is exercise therapy safe for people with adenomatous polyposis?

The research does not provide specific safety data for exercise therapy in adenomatous polyposis, but generally, physical activity is considered safe and may have health benefits, such as reducing the risk of colorectal cancer and improving fitness. ^{1 2 4 5 6}

How does Endurance Exercise Therapy differ from other treatments for adenomatous polyposis?

Endurance Exercise Therapy is unique because it focuses on improving physical fitness, which may help prevent the growth of colorectal adenomas (polyps) and reduce the risk of colorectal cancer in patients with familial adenomatous polyposis. Unlike traditional medical treatments, this therapy uses physical activity to potentially lower cancer risk by enhancing cardiorespiratory fitness and reducing polyp size. ^{1 2 4 5 7}

What is the purpose of this trial?

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.

Research Team

Samara Rifkin

Principal Investigator

University of Michigan Rogel Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of physical fitness on colorectal tumor development in patients with familial adenomatous polyposis. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Adenomatous polyp recurrence and physical activity in the Polyp Prevention Trial (United States). [2019]

3. England pubmed.ncbi.nlm.nih.gov

A meta-analysis of the association of physical activity with reduced risk of colorectal cancer. [2006]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Physical activity before and after diagnosis of colorectal cancer: disease risk, clinical outcomes, response pathways and biomarkers. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Physical Activity and Stool Metabolite Relationships Among Adults at High Risk for Colorectal Cancer. [2022]

6. Australia pubmed.ncbi.nlm.nih.gov

Active exercise after polypectomy reduces the risk of metachronous advanced colorectal neoplasm. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

[Effects of physical activity on cancer risk and disease progression after cancer diagnosis]. [2018]