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

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)

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Colon Cancer
• Intervention / Treatment: Drug: Aspirin; Drug: Vitamin D; Dietary supplement: Diet; Other: Physical Activity; Behavioral: Behavioral Support Counseling Sessions

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years at the time of study entry
• ECOG 0-1
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Aspirin, Vitamin D; by mouth every day for up to 90 days

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To estimate the ctDNA clearance rate of colorectal cancer patients with minimal residual disease	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Alisha Bent, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Actual): February 4, 2026
• Study Completion (Actual): February 4, 2026

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Colonic Neoplasms; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Diet, Food, and Nutrition; Physiological Phenomena; Hydrocarbons, Aromatic; Polycyclic Compounds; Nutritional Physiological Phenomena; Steroids; Fused-Ring Compounds; Phenols; Benzene Derivatives; Salicylates; Hydroxybenzoates; Secosteroids; Aspirin; Vitamin D; Exercise; Diet
• Other Study ID Numbers: 2021-0320; NCI-2021-09193 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No