ACTIVE_NOT_RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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

Quick Facts

Study Start:2021-10-12

Study Completion:2027-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05036109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Alisha Bent, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Alisha Bent, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-12

Study Completion Date2027-04-30

Study Record Updates

Study Start Date2021-10-12

Study Completion Date2027-04-30

Terms related to this study

Additional Relevant MeSH Terms

Colorectal Cancer
Colon Cancer