DAILY: Vitamin D, Aspirin, ExercIse, Low Saturated Fat Foods StudY in Colorectal Cancer Patients With Minimal Residual Disease
NCT ID: NCT05036109
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
16 participants
INTERVENTIONAL
2021-10-12
2027-04-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Aspirin, Vitamin D
by mouth every day for up to 90 days
Aspirin
by mouth every day for up to 90 days
Vitamin D
by mouth every day for up to 90 days
Diet
Patients will receive counseling promoting a plant-based diet and avoidance of Western dietary patterns in a one on one session with a licensed dietitian prior to day 1.
Physical Activity
The exercise goal is to increase recreational physical activity from baseline by at least 10 MET hours per week, which is equivalent to 150 minutes of moderate activity weekly
Behavioral Support Counseling Sessions
Patients will undergo a one-on-one counseling session prior to day 1
Interventions
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Aspirin
by mouth every day for up to 90 days
Vitamin D
by mouth every day for up to 90 days
Diet
Patients will receive counseling promoting a plant-based diet and avoidance of Western dietary patterns in a one on one session with a licensed dietitian prior to day 1.
Physical Activity
The exercise goal is to increase recreational physical activity from baseline by at least 10 MET hours per week, which is equivalent to 150 minutes of moderate activity weekly
Behavioral Support Counseling Sessions
Patients will undergo a one-on-one counseling session prior to day 1
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Alisha Bent, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2021-09193
Identifier Type: OTHER
Identifier Source: secondary_id
2021-0320
Identifier Type: -
Identifier Source: org_study_id
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