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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05036109

Collaborator

(none)

Enrollment

Location

Arm

7.6

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Colon Cancer	Drug: Aspirin Drug: Vitamin D Dietary Supplement: Diet Other: Physical Activity Behavioral: Behavioral Support Counseling Sessions	Early Phase 1

Detailed Description

Primary Objective:

To estimate the ctDNA clearance rate of colorectal cancer patients 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 To estimate the recurrence rate at 1 year in subjects who complete 3 months of optimal lifestyle interventions

Study Design

Study Type:

Interventional

Anticipated Enrollment :

17 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 12, 2021

Anticipated Primary Completion Date :

May 31, 2022

Anticipated Study Completion Date :

May 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Aspirin, Vitamin D by mouth every day for up to 90 days	Drug: Aspirin by mouth every day for up to 90 days Drug: 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

Arm

Intervention/Treatment

Other: Aspirin, Vitamin D

by mouth every day for up to 90 days

Drug: Aspirin

by mouth every day for up to 90 days

Drug: 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

Outcome Measures

Primary Outcome Measures

To estimate the ctDNA clearance rate of colorectal cancer patients with minimal residual disease [through study completion, an average of 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
Persistent hypercalcemia or conditions predisposing to hypercalcemia (i.e., hyperparathyroidism)
Known symptomatic genitourinary stones

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator: Scott Kopetz, MD, M.D. Anderson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

M D Anderson Cancer Center

Publications

None provided.

Responsible Party:

M.D. Anderson Cancer Center

ClinicalTrials.gov Identifier:

NCT05036109

Other Study ID Numbers:

2021-0320

First Posted:

Sep 5, 2021

Last Update Posted:

Nov 10, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 10, 2021