Lifestyle changes with vitamin D and aspirin for colorectal cancer patients
DAILY: Vitamin D, Aspirin, ExercIse, Low Saturated Fat Foods StudY in Colorectal Cancer Patients With Minimal Residual Disease
This study is testing if making lifestyle changes along with taking vitamin D and aspirin can help colorectal cancer patients lower their chances of the cancer coming back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 19 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05036109 on ClinicalTrials.gov |
What this trial studies
This study aims to determine if lifestyle modifications, including diet and exercise, combined with daily aspirin and vitamin D, can reduce the risk of colorectal cancer recurrence in patients with minimal residual disease. The primary objective is to estimate the clearance rate of circulating tumor DNA (ctDNA) after three months of these interventions. Secondary objectives include evaluating ctDNA dynamics and estimating the recurrence rate at one year for participants who complete the intervention. The study involves behavioral support counseling sessions to assist participants in making these lifestyle changes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with high-risk stage II, III, or IV colorectal adenocarcinoma who have no evidence of disease after local therapy and detectable ctDNA mutations.
Not a fit: Patients with concurrent malignancies, active gastrointestinal bleeding, or those unable to safely participate in physical activity may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the chances of colorectal cancer returning in patients with minimal residual disease.
How similar studies have performed: Other studies have shown promising results with lifestyle interventions in cancer care, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Scott Kopetz, MD — M.D. Anderson Cancer Center
- Study coordinator: scott Kopetz
- Email: skopetz@mdanderson.org
- Phone: (713) 792-2828
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.