Dietary Fiber for Colorectal Cancer

Overseen By Amber O'Connor

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OHSU Knight Cancer Institute

Disqualifiers: Active malignancy, Crohn's, Ulcerative colitis, Immunosuppressed, Hereditary colon cancer, others

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

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether daily fiber supplements can alter gut microorganisms to help prevent precancerous colon polyps. Since these polyps can sometimes lead to colon cancer, early intervention is crucial. Participants will take fiber orally for 28 days, and the study may include colon exams, such as proctoscopy or anoscopy with biopsy. Individuals with non-cancerous anorectal issues like hemorrhoids or those scheduled for a routine colonoscopy are ideal candidates. As an unphased trial, this study provides a unique opportunity to contribute to important research that could lead to new preventive strategies for colon health.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dietary fiber is generally safe for people. Many studies have linked higher fiber intake to a reduced risk of colon cancer. For example, one study found that individuals who consume a lot of fiber have a lower chance of developing colon polyps, which can lead to cancer. Another study demonstrated that high fiber intake is associated with lower rates of cancer recurrence and fewer deaths.

Dietary fiber is a common component of many diets and is found in foods like fruits, vegetables, and whole grains. Most people can consume it without issues. Some might experience mild side effects like bloating or gas, but these are usually not serious. Overall, the evidence suggests that dietary fiber supplements are safe to use in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for colorectal cancer, which often include surgery, chemotherapy, and radiation, the treatment in question uses dietary fiber. Researchers are excited about this approach because dietary fiber is a natural substance that may improve gut health and potentially reduce cancer risk with fewer side effects. This method is unique because it leverages the body's natural processes and could provide a non-invasive, easily accessible option for patients. Additionally, while traditional treatments focus on attacking cancer directly, dietary fiber might work by promoting a healthier colon environment, which is a novel angle in cancer therapy.

What evidence suggests that dietary fiber might be an effective treatment for colorectal cancer?

Research has shown that a high-fiber diet might help people with colorectal cancer live longer. In this trial, participants will receive dietary fiber as part of their supportive care. Studies have found that adding fiber to the diet after surgery can strengthen the immune system, reduce swelling, and help prevent tumor growth. Other research suggests that fiber consumption is linked to lower chances of cancer recurrence and reduced mortality rates. Fiber from whole grains is particularly effective at reducing the risk of colorectal cancer. Consuming an additional 10 grams of fiber daily might lower cancer risk by 10%. ^{2 3 6 7 8}

Who Is on the Research Team?

Vassiliki L Tsikitis, M.D.

Principal Investigator

OHSU Knight Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had a colonoscopy in the last 2 years and have benign anorectal issues like hemorrhoids, without cancer or Crohn's disease. They must understand and sign consent. It's not for those with hereditary colon cancer syndromes, past colon surgery, active malignancy, inflammatory bowel diseases or immunosuppression.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

I have issues like hemorrhoids or anal fissures but no cancer or Crohn's disease.

Exclusion Criteria

I have a genetic condition related to colon cancer.

I have had polyps or cancer in my colon or rectum.

I have had part or all of my colon surgically removed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dietary fiber orally once daily for 28 days

4 weeks

1 visit (in-person) for proctoscopy or anoscopy, blood sample collection

Follow-up

Participants are monitored for changes in microbiome diversity and abundance after fiber supplementation

up to 12 days

1 visit (in-person) for follow-up proctoscopy or anoscopy, blood sample collection

What Are the Treatments Tested in This Trial?

Interventions

• Dietary Fiber
• Proctoscopy or Anoscopy with Biopsy

Trial Overview The study investigates if taking daily dietary fiber supplements can alter the microorganisms in the gut lining to prevent precancerous polyps linked to colorectal cancer. Participants will undergo procedures like colonoscopy and answer questionnaires about their health.

How Is the Trial Designed?

Group I: Supportive care (oral fiber) Experimental Treatment 4 Interventions

Patients receive dietary fiber orally (PO) on study. QD for 28 days. Patients may undergo standard of care proctoscopy or anoscopy with biopsy on study and duringat follow- up or may undergo standard of care colonoscopy on study. All patients also undergo collection of blood samples on study and at follow up.

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9367345/

Association between Dietary Fiber Intake and Mortality ... Our results suggest that high dietary fiber intake may be associated with prolonged survival among CRC patients. Our findings add to the sparse ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11802429/

The impact of dietary fiber on colorectal cancer patients ... Postoperative dietary fiber administration in colorectal cancer enhances immune function, reduces disease-related inflammation, and inhibits tumor ...

3. foodandnutritionresearch.net foodandnutritionresearch.net/index.php/fnr/article/view/11034/18662

Dietary fiber consumption and outcomes of different cancers Our research consistently shows that dietary fiber is associated with lower incidence, recurrence, and mortality rates of colorectal cancer, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666154325003709

The association of dietary fiber intake with colorectal ... Specifically, fiber from whole grains consistently reduces CRC risk, while fruit fiber appears protective against CRA and EOCRC. Soluble and insoluble fibers, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1279770723003378

The Burden of Colorectal Cancer Attributable to Diet Low in ... Subsequent evidence indicated that dietary fiber intake reduced the risk of CRC, with an increase of 10 g total dietary fiber per day contributing to a 10% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4588743/

Dietary fiber intake and risk of colorectal cancer ... Results: Elevated total dietary fiber intake was associated with a significantly reduced risk of incident distal colorectal adenoma (ORhighest vs. lowest ...

7. nature.com nature.com/articles/s41467-024-55219-5

Diet-wide analyses for risk of colorectal cancer We report here on a systematic analysis of 97 dietary factors and subsequent colorectal cancer risk using a diet-wide association study

8. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/202011

Dietary Fiber Intake and Risk of Colorectal Cancer On the other hand, most prospective cohort studies have found no association between dietary fiber intake and risk of colorectal cancer or ...