Colorectal CancerNCT05036109
DAILY: Vitamin D, Aspirin, ExercIse, Low Saturated Fat Foods StudY in Colorectal Cancer Patients With Minimal Residual Disease
A study testing Aspirin, Vitamin D and Diet in people with Colorectal Cancer and Colon Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colon Cancer
- What is being tested?
- Aspirin, Vitamin D and Diet
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2021to 4 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Platelet count >50,000
- Ability to give informed consent
- Ability to complete all questionnaires involved in study
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
Read the 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
- Conditions
- Colorectal Cancer, Colon Cancer
- Being tested
- Aspirin, Vitamin D, Diet, Physical Activity, Behavioral Support Counseling Sessions
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
by mouth every day for up to 90 days
Vitamin DDrug
by mouth every day for up to 90 days
DietDietary supplement
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 ActivityOther
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 SessionsBehavioural
Patients will undergo a one-on-one counseling session prior to day 1
| Study group | Role | What they receive |
|---|---|---|
| Aspirin, Vitamin D | Other | by mouth every day for up to 90 days Receives: Drug: Aspirin; Drug: Vitamin D; Dietary Supplement: Diet; Other: Physical Activity; Behavioral: Behavioral Support Counseling Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the ctDNA clearance rate of colorectal cancer patients with minimal residual disease
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start12 Oct 2021
- Primary completion4 Feb 2026
- Study completion4 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alisha Bent, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036109
- Sponsor's protocol ID
- 2021-0320
- Other IDs
- NCI-2021-09193
- Status last verified
- Feb 2026
- First submitted
- 25 Aug 2021
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DAILY: Vitamin D, Aspirin, ExercIse, Low Saturated Fat Foods StudY in Colorectal Cancer Patients With Minimal Residual Disease
- ClinicalTrials.gov ID
- NCT05036109
- Acronym / sponsor ID
- 2021-0320
- Conditions
- Colorectal Cancer, Colon Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 4 Feb 2026 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aspirin, Vitamin D | Other | Drug: Aspirin, Drug: Vitamin D, Dietary Supplement: Diet, Other: Physical Activity, Behavioral: Behavioral Support Counseling Sessionsby mouth every day for up to 90 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirinby mouth every day for up to 90 days | Drug | Aspirin, Vitamin D |
| Vitamin Dby mouth every day for up to 90 days | Drug | Aspirin, Vitamin D |
| DietPatients 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. | Dietary supplement | Aspirin, Vitamin D |
| Physical ActivityThe 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 | Other | Aspirin, Vitamin D |
| Behavioral Support Counseling SessionsPatients will undergo a one-on-one counseling session prior to day 1 | Behavioural | Aspirin, Vitamin D |
Primary outcome
To estimate the ctDNA clearance rate of colorectal cancer patients with minimal residual disease
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alisha Bent, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin, Vitamin D and Diet in people with Colorectal Cancer and Colon Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the ctDNA clearance rate of colorectal cancer patients with minimal residual disease (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.