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

• Status: Recruiting
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Aspirin; Vitamin D

Criteria

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