NCT05036109CompletedNot Applicable

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

M.D. Anderson Cancer Center1 site in 1 country16 target enrollmentStarted: October 12, 2021Last updated: February 10, 2026

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor: M.D. Anderson Cancer Center
Enrollment: 16
Locations: 1
Primary Endpoint: To estimate the ctDNA clearance rate of colorectal cancer patients with minimal residual disease

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief 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

Study Design

Study Type: Interventional
Allocation: Na
Intervention Model: Single Group
Primary Purpose: Prevention
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•Age ≥ 18 years at the time of study entry
•Histologically documented high-risk stage II, stage III, or stage IV colorectal adenocarcinoma with no evidence of disease following definitive local therapy (including surgical resection or ablation)
•No radiographic evidence of disease by contrast enhanced CT chest/abdomen/pelvis
•Presence of detectable ctDNA mutation that matches mutations found in tumor tissue
•Completion of all standard of care adjuvant therapy
•Platelet count >50,000
•Ability to give informed consent
•Ability to complete all questionnaires involved in study

Exclusion Criteria

•Concurrent malignancy under active treatment
•Known active gastrointestinal bleeding or peptic ulcer disease
•Known hypersensitivity to vitamin D or aspirin
•CrCl<30 mL/min within 30 days of starting the intervention
•Current usage of therapeutic anticoagulation (warfarin, Eliquis, Xarelto)
•Inability to safely participate in physical activity in the opinion of the treating oncologist
•Pregnant or nursing women. N.B.: urine pregnancy test will be administered as part of the screening process.
•Persistent hypercalcemia or conditions predisposing to hypercalcemia (i.e., hyperparathyroidism)
•Known symptomatic genitourinary stones