NCT05036109

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if lifestyle changes (such as diet and exercise) combined with daily aspirin and vitamin D can affect the likelihood of advanced colorectal cancer coming back (recurring)

Detailed description

Primary Objective: To estimate the ctDNA clearance rate of colorectal cancer participants with minimal residual disease after 3 months of optimal lifestyle interventions Secondary Objectives: * To evaluate the dynamics of ctDNA allele fractions after 3 months of optimal lifestyle interventions and every 3 months thereafter up to 12 months * To estimate the recurrence rate at 1 year in subjects who complete 3 months of optimal lifestyle interventions

Conditions

• Colorectal Cancer
• Colon Cancer

Interventions

Type	Name	Description
DRUG	Aspirin	by mouth every day for up to 90 days
DRUG	Vitamin D	by mouth every day for up to 90 days
DIETARY_SUPPLEMENT	Diet	Patients will receive counseling promoting a plant-based diet and avoidance of Western dietary patterns in a one on one session with a licensed dietitian prior to day 1.
OTHER	Physical Activity	The exercise goal is to increase recreational physical activity from baseline by at least 10 MET hours per week, which is equivalent to 150 minutes of moderate activity weekly
BEHAVIORAL	Behavioral Support Counseling Sessions	Patients will undergo a one-on-one counseling session prior to day 1

Timeline

• Start date: 2021-10-12
• Primary completion: 2026-02-04
• Completion: 2026-02-04
• First posted: 2021-09-05
• Last updated: 2026-02-10

Locations

1 site across 1 country: United States