Colon Cancer, Colorectal Cancer
Conditions
Brief 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)
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
Interventions
DRUGAspirin
by mouth every day for up to 90 days
DRUGVitamin D
by mouth every day for up to 90 days
DIETARY_SUPPLEMENTDiet
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.
OTHERPhysical 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
BEHAVIORALBehavioral Support Counseling Sessions
Patients will undergo a one-on-one counseling session prior to day 1
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate the ctDNA clearance rate of colorectal cancer patients with minimal residual disease | through study completion, an average of 1 year |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlisha Bent, MD
M.D. Anderson Cancer Center
Outcome results
None listed