This clinical trial investigates 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). Aspirin may help block the formation of growths that may become cancer. Vitamin D is associated with a decreased risk of colorectal cancer and increased survival after colorectal cancer treatment. Physical activity is associated with decrease risk of colorectal cancer. Lifestyle changes combined with aspirin and vitamin D may or may not help to lower the risk of colorectal cancer returning.
Additional locations may be listed on ClinicalTrials.gov for NCT05036109.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To estimate the circulating tumor deoxyribonucleic acid (ctDNA) clearance rate of colorectal cancer patients with minimal residual disease after 3 months of optimal lifestyle interventions.
SECONDARY OBJECTIVES:
I. To evaluate the dynamics of ctDNA allele fractions after 3 months of optimal lifestyle interventions and every 3 months thereafter up to 12 months.
II. To estimate the recurrence rate at 1 year in subjects who complete 3 months of optimal lifestyle interventions.
EXPLORATORY OBJECTIVE:
I. To confirm ctDNA clearance by utilizing an independent assay.
OUTLINE:
Patient receive dietary counseling with a licensed dietician over 15-20 minutes prior to day 1 to discuss diet and to make suggestions on possible diet changes. Patients also receive coaching sessions over 15-20 minutes with dietician twice monthly for 3 months. Patients receive aspirin orally (PO) once daily (QD) and cholecalciferol (vitamin D) PO QD for 90 days. Patients also wear Fitbit for 90 days.
After completion of study intervention, patients are followed up every 3 months for 12 months.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorAlisha Bent