NCT05036109已完成不适用
DAILY: Vitamin D, Aspirin, ExercIse, Low Saturated Fat Foods StudY in Colorectal Cancer Patients With Minimal Residual Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To estimate the ctDNA clearance rate of colorectal cancer patients with minimal residual disease
研究概览
简要总结
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)
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years at the time of study entry
- •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
排除标准
- •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
研究组 & 干预措施
Aspirin, Vitamin D
Other
by mouth every day for up to 90 days
干预措施: Aspirin (Drug)
Aspirin, Vitamin D
Other
by mouth every day for up to 90 days
干预措施: Vitamin D (Drug)
Aspirin, Vitamin D
Other
by mouth every day for up to 90 days
干预措施: Diet (Dietary Supplement)
Aspirin, Vitamin D
Other
by mouth every day for up to 90 days
干预措施: Physical Activity (Other)
Aspirin, Vitamin D
Other
by mouth every day for up to 90 days
干预措施: Behavioral Support Counseling Sessions (Behavioral)
结局指标
主要结局
To estimate the ctDNA clearance rate of colorectal cancer patients with minimal residual disease
时间窗: through study completion, an average of 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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