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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial will test if changes in lifestyle combined with aspirin and vitamin D can prevent colorectal cancer from recurring.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To estimate the ctDNA clearance rate of colorectal cancer patients with minimal residual disease

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

~3470

Diet

2000

Completed Phase 4

~15300

Aspirin

2014

Completed Phase 4

~55580

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,327 Total Patients Enrolled

Scott Kopetz, MDPrincipal InvestigatorM.D. Anderson Cancer Center

4 Previous Clinical Trials

1,421 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings remaining for participants in this research?

"Affirmative, the information accessible on clinicaltrials.gov reveals that this trial is actively enlisting patients. This research was first advertised on October 12th 2021 and last revised November 16th 2022. There are 17 participants to be recruited from 1 site for this study."

Answered by AI

Does this clinical trial break any new ground in the field?

"Since 2005, Abbott has sponsored the initial research of this medication. The first trial in that year included 15480 participants and led to its Phase 4 drug approval. At present, there are 199 ongoing studies related to it occurring over 1406 cities and 58 countries worldwide."

Answered by AI

Could you please outline the research that has been done on this specific treatment?

"Currently, there are 199 live clinical trials researching this specific treatment with 59 in Phase 3. Of these sites, 3878 locations around the globe have commenced studies for said remedy, including several within Shanghai itself."

Answered by AI

What conditions does this therapeutic intervention typically alleviate?

"This therapy, usually applied to treat percutaneous coronary intervention (pci), has also been demonstrated as effective for dental procedures, inflammation and neck pain."

Answered by AI

What is the current cohort of patients participating in this experiment?

"Affirmative. According to the information posted on clinicaltrials.gov, this medical trial is presently recruiting participants. This research was initially published online on October 12th 2021 and has since been amended November 16th 2022. 17 individuals are sought from a single location for inclusion in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DAILY: Vitamin D, Aspirin, ExercIse, Low Saturated Fat Foods StudY in Colorectal Cancer Patients With Minimal Residual Disease

2021. "DAILY: Vitamin D, Aspirin, ExercIse, Low Saturated Fat Foods StudY in Colorectal Cancer Patients With Minimal Residual Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05036109.

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