Colon Cancer Clinical Trial

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

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)

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Full Description

Primary Objective:

To estimate the ctDNA clearance rate of colorectal cancer patients 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 To estimate the recurrence rate at 1 year in subjects who complete 3 months of optimal lifestyle interventions

View Eligibility Criteria

Eligibility 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 mLmin 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

Study is for people with:

Colon Cancer

Estimated Enrollment:

17

Study ID:

NCT05036109

Recruitment Status:

Recruiting

Sponsor:

M.D. Anderson Cancer Center

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There is 1 Location for this study

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M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Scott Kopetz, MD
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Scott Kopetz, MD
Principal Investigator

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Study is for people with:

Colon Cancer

Estimated Enrollment:

17

Study ID:

NCT05036109

Recruitment Status:

Recruiting

Sponsor:


M.D. Anderson Cancer Center

How clear is this clinincal trial information?

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