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

Not Applicable

Recruiting

• Conditions: Colorectal Cancer; Colon Cancer

• Registration Number: NCT05036109
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-8-25
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Inclusion Criteria:<br><br> - Age = 18 years at the time of study entry<br><br> - ECOG 0-1<br><br> - Histologically documented high-risk stage II, stage III, or stage IV colorectal<br> adenocarcinoma with no evidence of disease following definitive local therapy<br> (including surgical resection or ablation)<br><br> - No radiographic evidence of disease by contrast enhanced CT chest/abdomen/pelvis<br><br> - Presence of detectable ctDNA mutation that matches mutations found in tumor tissue<br><br> - Completion of all standard of care adjuvant therapy<br><br> - Platelet count >50,000<br><br> - Ability to give informed consent<br><br> - Ability to complete all questionnaires involved in study<br><br>Exclusion Criteria:<br><br> - Concurrent malignancy under active treatment<br><br> - Known active gastrointestinal bleeding or peptic ulcer disease<br><br> - Known hypersensitivity to vitamin D or aspirin<br><br> - CrCl<30 mL/min within 30 days of starting the intervention<br><br> - Current usage of therapeutic anticoagulation (warfarin, Eliquis, Xarelto)<br><br> - Inability to safely participate in physical activity in the opinion of the treating<br> oncologist<br><br> - Pregnant or nursing women. N.B.: urine pregnancy test will be administered as part<br> of the screening process.<br><br> - Persistent hypercalcemia or conditions predisposing to hypercalcemia (i.e.,<br> hyperparathyroidism)<br><br> - Known symptomatic genitourinary stones

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To estimate the ctDNA clearance rate of colorectal cancer patients with minimal residual disease