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

Study Overview
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Brief Summary
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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
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Primary Objective: To estimate the ctDNA clearance rate of colorectal cancer patients 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 To estimate the recurrence rate at 1 year in subjects who complete 3 months of optimal lifestyle interventions

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

Conditions
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Colorectal Cancer, Colon Cancer

Intervention / Treatment
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* Drug: Aspirin
* Drug: Vitamin D
* Dietary Supplement: Diet
* Other: Physical Activity
* Behavioral: Behavioral Support Counseling Sessions


Participation Criteria
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Eligibility Criteria
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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 Persistent hypercalcemia or conditions predisposing to hypercalcemia (i.e., hyperparathyroidism) Known symptomatic genitourinary stones

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Aspirin, Vitamin D<br>by mouth every day for up to 90 days | Drug: Aspirin<br>* by mouth every day for up to 90 days<br>Drug: Vitamin D<br>* by mouth every day for up to 90 days<br>Dietary Supplement: Diet<br>* 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.<br>Other: Physical Activity<br>* 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<br>Behavioral: Behavioral Support Counseling Sessions<br>* Patients will undergo a one-on-one counseling session prior to day 1<br>|

What is the study measuring?
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Primary Outcome Measures

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