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

Last updated: February 6, 2026
Sponsor: M.D. Anderson Cancer Center
Overall Status: Completed

Phase

N/A

Condition

Colorectal Cancer

Cancer

Rectal Cancer

Treatment

Aspirin

Physical Activity

Behavioral Support Counseling Sessions

Clinical Study ID

NCT05036109
2021-0320
NCI-2021-09193
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

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 colorectaladenocarcinoma 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

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 treatingoncologist

  • Pregnant or nursing women. N.B.: urine pregnancy test will be administered as partof the screening process.

  • Persistent hypercalcemia or conditions predisposing to hypercalcemia (i.e.,hyperparathyroidism)

  • Known symptomatic genitourinary stones

Study Design

Total Participants: 16
Treatment Group(s): 5
Primary Treatment: Aspirin
Phase:
Study Start date:
October 12, 2021
Estimated Completion Date:
February 04, 2026

Study 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

Connect with a study center

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • M D Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

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