Overview

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