Lifestyle Changes + Aspirin + Vitamin D for Colorectal Cancer

Overseen By scott Kopetz

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must be taking: Aspirin, Vitamin D

Must not be taking: Anticoagulants

Disqualifiers: Concurrent malignancy, Active bleeding, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether lifestyle changes, such as improving diet and exercise, combined with aspirin and vitamin D, can prevent the recurrence of advanced colorectal cancer. The study targets individuals who have had colorectal cancer but currently show no signs of the disease after treatment. Participants must have a specific genetic marker in their blood that matches their previous tumor. As an unphased trial, this study provides a unique opportunity to contribute to understanding how lifestyle changes and supplements might prevent cancer recurrence.

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

The trial requires that you do not use certain blood thinners like warfarin, Eliquis, or Xarelto. If you are on these medications, you would need to stop them to participate.

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

Research shows that aspirin can increase the risk of bleeding, particularly in the stomach and intestines. This is crucial for anyone considering joining a trial. Studies have produced mixed results on whether aspirin aids in surviving colorectal cancer.

Regarding vitamin D, studies have not demonstrated that it enhances aspirin’s ability to prevent colon cancer. There is little evidence of serious side effects from vitamin D when taken in normal amounts, but monitoring your body's reaction is advisable.

In summary, both aspirin and vitamin D are generally safe, but aspirin can cause bleeding issues. Anyone considering this trial should consider these factors and possibly discuss them with a doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for colorectal cancer because they combine lifestyle changes with common supplements, potentially offering a more holistic approach. Unlike standard treatments like chemotherapy and surgery, this approach uses aspirin and vitamin D, which are thought to have anti-inflammatory and cancer-preventive properties. Additionally, incorporating behavioral support, diet, and physical activity into the regimen could enhance overall well-being and effectiveness, making it a more comprehensive strategy for managing the disease.

What evidence suggests that this trial's treatments could be effective for colorectal cancer?

Research has shown that aspirin, one of the treatments in this trial, can help protect against colorectal cancer (CRC) and may improve survival rates. It reduces abnormal growths in the colon by 65%, lowering the risk of these growths becoming cancerous. Vitamin D, another treatment option in this trial, also reduces these early changes in the colon when taken alone. However, combining aspirin and vitamin D, as studied in this trial, does not significantly enhance this protective effect. Although results on aspirin's impact on CRC survival are mixed, it remains a widely studied option for preventing CRC. ^{1 2 3 4 6}

Who Is on the Research Team?

Alisha Bent, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

No radiographic evidence of disease by contrast enhanced CT chest/abdomen/pelvis

My blood test shows cancer DNA that matches my tumor.

Platelet count >50,000

Exclusion Criteria

I currently have active stomach bleeding or ulcers.

My doctor thinks it's unsafe for me to do physical activities.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily aspirin and vitamin D, along with lifestyle interventions such as diet and exercise, for up to 90 days

12 weeks

Follow-up

Participants are monitored for ctDNA dynamics and recurrence rate every 3 months after treatment, up to 12 months

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Aspirin
• Behavioral Support Counseling Sessions
• Diet
• Physical Activity
• Vitamin D

Trial Overview

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.

How Is the Trial Designed?

Group I: Aspirin, Vitamin D Experimental Treatment 5 Interventions

by mouth every day for up to 90 days

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

Clinicians believe that low-dose aspirin is a safe and cost-effective option for reducing the risk of colorectal cancer in adults aged 50-70, but there are barriers to implementing the new guidelines, such as uncertainty about dosage and the strength of the evidence.

General practitioners (GPs) are seen as crucial for the successful adoption of these guidelines, and support from trusted organizations like Cancer Council Australia could facilitate wider implementation in the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinicians' opinions on recommending aspirin to prevent colorectal cancer to Australians aged 50-70 years: a qualitative study. Milton, S., McIntosh, J., Yogaparan, T., et al.[2021]

Regular use of aspirin significantly reduces the incidence of colonic adenomas and colorectal cancer, particularly when taken at high doses for more than 10 years, with relative risk reductions observed in various study types (RCTs, case-control, and cohort studies).

However, aspirin use is associated with an increased risk of gastrointestinal complications, highlighting the need to weigh the benefits against potential harms when considering aspirin for cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of aspirin for primary prevention of colorectal cancer: a systematic review prepared for the U.S. Preventive Services Task Force. Dubé, C., Rostom, A., Lewin, G., et al.[2022]

A randomized trial involving 1107 patients found that a combination of calcitriol, aspirin, and calcium carbonate did not significantly reduce the recurrence of colorectal adenomas over a 3-year period, leading to the study's early termination due to futility.

The study indicated that smoking status might influence treatment effects, with nonsmokers showing a potential benefit while current smokers did not, although these interactions were not statistically significant overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspirin, Calcitriol, and Calcium Do Not Prevent Adenoma Recurrence in a Randomized Controlled Trial. Pommergaard, HC., Burcharth, J., Rosenberg, J., et al.[2022]

Increased physical activity and avoiding a Western pattern diet after a colorectal cancer diagnosis are linked to lower recurrence rates and better overall survival, based on prospective observational studies.

Obesity (BMI ≥35 kg/m²) is associated with a higher risk of cancer recurrence, while regular use of aspirin or COX-2 inhibitors may help reduce recurrence rates and improve vitamin D levels in colorectal cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond standard adjuvant therapy for colon cancer: role of nonstandard interventions. Meyerhardt, JA.[2021]

A study reanalyzing data from two Japanese clinical trials found that the effectiveness of low-dose aspirin (100 mg/day) in preventing colorectal tumors is influenced by variations in the CYP2A6 gene, which affects enzyme activity.

Participants with the wild-type CYP2A6 genotype showed reduced chemopreventive effects from aspirin, suggesting that CYP2A6 genotyping could help personalize colorectal cancer prevention strategies using aspirin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of polymorphic cytochrome P450 2A6 genotypes on chemoprevention against colorectal tumors in single Japanese cohort using daily low-dose aspirin: insights into future personalized treatments. Yamazaki, H., Shimizu, M., Otani, T., et al.[2021]

In a study of 37,916 women over an average of 10.1 years, higher dietary intakes of folate and vitamin B6 were linked to a reduced risk of colorectal cancer, particularly in those not taking supplements.

Total intakes of folate and vitamin B6 did not show a significant association with colorectal cancer risk, suggesting that the source of these nutrients (dietary vs. supplements) may play a crucial role in their protective effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Folate, vitamin B6, multivitamin supplements, and colorectal cancer risk in women. Zhang, SM., Moore, SC., Lin, J., et al.[2018]

Aspirin chemoprophylaxis, while potentially reducing colorectal cancer risk by 30%, was found to be non-cost-effective as an adjunct to screening methods like sigmoidoscopy or colonoscopy, leading to increased costs and fewer life-years gained due to complications.

The study suggests that aspirin should not replace colorectal cancer screening, and public health efforts should prioritize improving adherence to screening protocols rather than relying on aspirin for cancer prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspirin as an adjunct to screening for prevention of sporadic colorectal cancer. A cost-effectiveness analysis. Ladabaum, U., Chopra, CL., Huang, G., et al.[2019]

Regular aspirin use is associated with a significant reduction in the risk of colorectal cancer and polyps, with studies indicating a risk reduction of about 50% in most cases, based on seven recent epidemiologic studies.

However, a randomized trial found that a standard dose of aspirin (325 mg every other day) did not lower colorectal cancer incidence over five years, highlighting the need for further research to clarify optimal dosing, duration, and the effects of discontinuation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspirin and the prevention of colorectal cancer: a review of the evidence. Paganini-Hill, A.[2019]

Aspirin and other NSAIDs show promise in preventing colorectal cancer and potentially other cancers, but more research is needed to fully understand their risk-benefit profiles and to make definitive recommendations.

Aspirin is favored for chemoprevention due to its cardiovascular benefits, but studies are required to determine the optimal dosage, treatment duration, and specific populations that would benefit most while minimizing side effects like peptic ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspirin and non-steroidal anti-inflammatory drugs for cancer prevention: an international consensus statement. Cuzick, J., Otto, F., Baron, JA., et al.[2022]

Non-aspirin NSAIDs were found to be the most effective agents for preventing advanced metachronous neoplasia in individuals with a history of colorectal neoplasia, based on a systematic review of 15 trials involving 12,234 patients.

Low-dose aspirin, while less effective than non-aspirin NSAIDs, was ranked as the safest option among the chemoprevention agents, indicating a favorable risk-to-benefit profile for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemoprevention of colorectal cancer in individuals with previous colorectal neoplasia: systematic review and network meta-analysis. Dulai, PS., Singh, S., Marquez, E., et al.[2022]

Aspirin and NSAIDs have shown potential in preventing colorectal cancer and its precursor adenomas, but their use is complicated by significant risks, such as increased chances of hemorrhagic stroke, necessitating further research before making general recommendations.

In the meantime, a healthy lifestyle that includes a diet rich in vegetables and fiber, regular exercise, and maintaining a healthy weight is recommended for colorectal cancer prevention, as these factors have been associated with reduced risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspirin and other nonsteroidal anti-inflammatory agents in the prevention of colorectal cancer. Sandler, RS.[2013]

Citations

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Scope: Aspirin is the most extensively studied agent, with substantial evidence supporting its protective effect on CRC-specific survival, ...

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Aspirin reduces colon ACF by 65 %, lowering oxidative stress and DNA damage. · Vitamin D alone suppresses ACF and liver DNA damage; vitamin C shows limited ...

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Does Regular Use of Aspirin Improve Colorectal Cancer ...

Research results have been mixed about whether regularly taking aspirin or another NSAID helps improve the survival of people who have been diagnosed with CRC.

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Chemoprevention of Colorectal Cancer—With Emphasis ...

In this review, we summarize current evidence on the association between CRC outcomes and the use of aspirin, OACs, metformin, and corticosteroids.

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Aspirin Use to Prevent Cardiovascular Disease and ...

However, one of these trials, ASPREE, found a concerning and statistically significant increase in CRC mortality for aspirin users over this 5- ...

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pmc.ncbi.nlm.nih.gov

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Aspirin and cancer: biological mechanisms and clinical ...

With an average follow-up of only 4.7 years, cancer-related deaths occurred in 3.1% of the ten thousand participants randomized to aspirin, and ...