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
• Interventions: Drug: Aspirin; Drug: Vitamin D; Dietary Supplement: Diet; Other: Physical Activity; Behavioral: Behavioral Support Counseling Sessions

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

Brief 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)

Detailed 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

Study Timeline

• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-08-30
• Study First Posted: 2021-09-05
• Study Start: 2021-10-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aspirin, Vitamin D	Diet	by mouth every day for up to 90 days
Aspirin, Vitamin D	Physical Activity	by mouth every day for up to 90 days
Aspirin, Vitamin D	Behavioral Support Counseling Sessions	by mouth every day for up to 90 days
Aspirin, Vitamin D	Aspirin	by mouth every day for up to 90 days
Aspirin, Vitamin D	Vitamin D	by mouth every day for up to 90 days

Primary Outcome Measures

Name	Time	Method
To estimate the ctDNA clearance rate of colorectal cancer patients with minimal residual disease	through study completion, an average of 1 year

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States