DAILY: Vitamin D, Aspirin, ExercIse, Low Saturated Fat Foods StudY in Colorectal Cancer Patients With Minimal Residual Disease

Colorectal Cancer Clinical Trial

Official title:

DAILY: Vitamin D, Aspirin, ExercIse, Low Saturated Fat Foods StudY in Colorectal Cancer Patients With Minimal Residual Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05036109
• Other study ID #: 2021-0320
• Secondary ID: NCI-2021-09193
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: scott Kopetz
• Phone: (713) 792-2828
• Email: skopetz[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 19
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Neoplasm, Residual

Intervention

Drug:
• Aspirin
by mouth every day for up to 90 days
• Vitamin D
by mouth every day for up to 90 days

Dietary Supplement:
• 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.

Other:
• 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:
• Behavioral Support Counseling Sessions
Patients will undergo a one-on-one counseling session prior to day 1

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the ctDNA clearance rate of colorectal cancer patients with minimal residual disease		through study completion, an average of 1 year

External Links

•   M D Anderson Cancer Center