Back to resultsDAILY: Vitamin D, Aspirin, ExercIse, Low Saturated Fat Foods StudY in Colorectal Cancer Patients With Minimal Residual Disease
Primary Purpose
Colorectal Cancer, Colon Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aspirin
Vitamin D
Diet
Physical Activity
Behavioral Support Counseling Sessions
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
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
Sites / Locations
- M D Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Aspirin, Vitamin D
Arm Description
by mouth every day for up to 90 days
Outcomes
Primary Outcome Measures
To estimate the ctDNA clearance rate of colorectal cancer patients with minimal residual disease
Secondary Outcome Measures
Full Information
NCT ID
NCT05036109
First Posted
August 25, 2021
Last Updated
October 9, 2023
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05036109
Brief Title
DAILY: Vitamin D, Aspirin, ExercIse, Low Saturated Fat Foods StudY in Colorectal Cancer Patients With Minimal Residual Disease
Official Title
DAILY: Vitamin D, Aspirin, ExercIse, Low Saturated Fat Foods StudY in Colorectal Cancer Patients With Minimal Residual Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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)
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colon Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aspirin, Vitamin D
Arm Type
Other
Arm Description
by mouth every day for up to 90 days
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
by mouth every day for up to 90 days
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
by mouth every day for up to 90 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physical Activity
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Support Counseling Sessions
Intervention Description
Patients will undergo a one-on-one counseling session prior to day 1
Primary Outcome Measure Information:
Title
To estimate the ctDNA clearance rate of colorectal cancer patients with minimal residual disease
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
scott Kopetz
Phone
(713) 792-2828
Email
skopetz@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Kopetz, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Kopetz, MD
First Name & Middle Initial & Last Name & Degree
Scott Kopetz, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center
Learn more about this trial
DAILY: Vitamin D, Aspirin, ExercIse, Low Saturated Fat Foods StudY in Colorectal Cancer Patients With Minimal Residual Disease
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