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

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    17
  • sponsor
    M.D. Anderson Cancer Center
Updated on 22 October 2022

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 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

Details
Condition Colorectal Cancer, Colon Cancer
Treatment diet, Aspirin, physical activity, Vitamin D, Behavioral Support Counseling Sessions
Clinical Study IdentifierNCT05036109
SponsorM.D. Anderson Cancer Center
Last Modified on22 October 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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