Clinical trial · Interventional
DAILY: Vitamin D, Aspirin, ExercIse, Low Saturated Fat Foods StudY in Colorectal Cancer Patients With Minimal Residual Disease
NCT05036109CI-TRIAL-00102905completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aspirin | Drug | Aspirin | ALIAS |
| Behavioral Support Counseling Sessions | Behavioral | — | UNRESOLVED |
| Diet | Dietary Supplement | — | UNRESOLVED |
| Physical Activity | Other | — | UNRESOLVED |
| Vitamin D | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Aspirin, Vitamin D
- description
- by mouth every day for up to 90 days
- interventionNames
- Drug: Aspirin
- Drug: Vitamin D
- Dietary Supplement: Diet
- Other: Physical Activity
- Behavioral: Behavioral Support Counseling Sessions
Primary outcomes (1)
- measure
- To estimate the ctDNA clearance rate of colorectal cancer patients with minimal residual disease
- timeFrame
- through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.