What side effects are associated with this type of intervention?

Common treatments for colorectal cancer include lifestyle changes, aspirin, and vitamin D supplementation. Lifestyle changes such as increased physical activity and dietary modifications generally have minimal side effects but can improve overall health and reduce fatigue. Aspirin, while beneficial in reducing the risk of recurrent adenomas and colorectal cancer, can cause gastrointestinal issues such as ulcers and bleeding, especially with long-term use. Vitamin D supplementation is generally well-tolerated, but excessive intake can lead to hypercalcemia, which may cause nausea, weakness, and kidney problems. Combining these treatments may enhance efficacy while minimizing individual side effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of colorectal cancer, including chemotherapeutic agents like 5-fluorouracil (5-FU) and oxaliplatin, as well as targeted therapies such as bevacizumab and cetuximab. Aspirin, known for its anti-inflammatory and anti-platelet effects, has shown promise in reducing the risk of colorectal adenomas and cancer recurrence in clinical trials, although it is not specifically FDA-approved for colorectal cancer prevention. Vitamin D, which plays a role in cell growth regulation and immune function, has been associated with improved survival outcomes in observational studies, but it is not yet FDA-approved as a treatment for colorectal cancer. These treatments align with the mechanisms being studied in the trial focusing on lifestyle changes, aspirin, and vitamin D.

What other types of research exist?

Promising novel alternatives for colorectal cancer patients considering treatment in 2024 include: 1) Nonsteroidal anti-inflammatory drugs (NSAIDs) like indomethacin, which have shown potential in combination with vitamin D to reduce cancer risk. 2) Omega-3 fatty acids, which have been indicated to reverse abnormal cell proliferation and reduce adenoma burden. 3) High vegetable fiber diets, particularly those rich in cereal fiber, which may enhance the apoptotic response to DNA damage and lower mortality rates. These alternatives offer potential benefits in cancer prevention and treatment, though further clinical trials are needed to confirm their efficacy.

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Lifestyle Changes + Aspirin + Vitamin D for Colorectal Cancer

N/A

Recruiting

Led By Scott Kopetz, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of detectable ctDNA mutation that matches mutations found in tumor tissue

Completion of all standard of care adjuvant therapy

Must not have

Known active gastrointestinal bleeding or peptic ulcer disease

Current usage of therapeutic anticoagulation (warfarin, Eliquis, Xarelto)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if healthy lifestyle changes, along with daily aspirin and vitamin D, can help prevent colorectal cancer from coming back in patients who have a small amount of cancer left after treatment. The goal is to see if these interventions can clear the remaining cancer cells and reduce the chance of it coming back. The study will measure how well these methods work over time. Aspirin has been shown in multiple studies to reduce the risk of colorectal cancer incidence, coming back, and death.

Who is the study for?

This trial is for adults over 18 with high-risk stage II, III, or IV colorectal cancer who've had surgery or ablation and show no signs of disease. They must have a certain blood cell count, be able to consent and fill out questionnaires. It's not for those allergic to vitamin D or aspirin, on active treatment for another cancer, with kidney issues, pregnant/nursing women, prone to hypercalcemia or urinary stones, have GI bleeding/ulcers, are on certain blood thinners or can't exercise safely.

What is being tested?

The study tests if lifestyle changes like diet and exercise along with daily aspirin and vitamin D can prevent advanced colorectal cancer from returning. Participants will also receive behavioral support counseling sessions to help maintain these lifestyle adjustments.

What are the potential side effects?

Possible side effects may include reactions related to aspirin such as gastrointestinal issues (like ulcers), increased risk of bleeding; too much vitamin D might lead to high calcium levels in the blood which could cause kidney problems; dietary changes could affect digestion; physical activity carries a risk of injury.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood test shows cancer DNA that matches my tumor.

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I have finished all my standard cancer treatments.

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My colorectal cancer is high-risk but shows no signs after treatment.

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I am 18 years old or older.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have active stomach bleeding or ulcers.

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I am currently taking blood thinners like warfarin, Eliquis, or Xarelto.

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I have long-lasting high calcium levels or a condition that can cause this.

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I am currently receiving treatment for another cancer.

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I have painful kidney or bladder stones.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: Aspirin, Vitamin DExperimental Treatment5 Interventions

by mouth every day for up to 90 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vitamin D

2013

Completed Phase 4

~3670

Aspirin

2014

Completed Phase 4

~55580

Diet

2000

Completed Phase 4

~15070

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for colorectal cancer include lifestyle changes, aspirin, and vitamin D. Lifestyle changes such as increased physical activity and a healthy diet can improve overall health and immune function, potentially reducing cancer recurrence. Aspirin, a nonsteroidal anti-inflammatory drug (NSAID), has anti-inflammatory and anti-platelet effects that may inhibit tumor growth and reduce the risk of cancer recurrence. Vitamin D is thought to regulate cell growth and enhance immune function, which could improve cancer prognosis. These treatments are important for colorectal cancer patients as they may offer additional benefits beyond traditional therapies, potentially improving survival and quality of life.

Anthocyanins in Colorectal Cancer Prevention. A Systematic Review of the Literature in Search of Molecular Oncotargets.