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

NCT05036109 | Completed DMC

• 2 other identifiers: 2021-0320NCI-2021-09193
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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)

Conditions

Colorectal Cancer; Colon Cancer

Outcome Measures

Primary Outcomes (1)

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

  through study completion, an average of 1 year

Study Arms (1)

Aspirin, Vitamin D

OTHER

by mouth every day for up to 90 days

Drug: Aspirin; Drug: Vitamin D; Dietary Supplement: Diet; Other: Physical Activity; Behavioral: Behavioral Support Counseling Sessions

Interventions

Aspirin DRUG

by mouth every day for up to 90 days

Aspirin, Vitamin D

Vitamin D DRUG

by mouth every day for up to 90 days

Aspirin, Vitamin D

Diet DIETARY_SUPPLEMENT

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.

Aspirin, Vitamin D

Physical Activity OTHER

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

Aspirin, Vitamin D

Behavioral Support Counseling Sessions BEHAVIORAL

Patients will undergo a one-on-one counseling session prior to day 1

Aspirin, Vitamin D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Aspirin; Vitamin D; Diet; Exercise

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alisha Bent, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 5, 2021
• Study Start: October 12, 2021
• Primary Completion: February 4, 2026
• Study Completion: February 4, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)