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

M.D. Anderson Cancer Center

Status

Active, not recruiting

Conditions

Colon Cancer

Colorectal Cancer

Treatments

Drug: Vitamin D

Behavioral: Behavioral Support Counseling Sessions

Other: Physical Activity

Dietary Supplement: Diet

Drug: Aspirin

Study type

Interventional

Funder types

Other

Identifiers

NCT05036109

NCI-2021-09193 (Other Identifier)

2021-0320

Details and patient eligibility

About

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)

Full 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

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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. N.B.: urine pregnancy test will be administered as part of the screening process.
Persistent hypercalcemia or conditions predisposing to hypercalcemia (i.e., hyperparathyroidism)
Known symptomatic genitourinary stones