A Pilot Study to Determine the Feasibility of a Low Glycemic Load Diet in Patients With Stage I-III Colon Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Individual patient compliance, defined by following assigned target glycemic load index >= 75% of the time between weeks 4 and 12
研究概览
简要总结
This pilot clinical trial studies the feasibility of a low glycemic load diet in patients with stage I-III colon cancer. A low glycemic load diet includes foods that have low scores on the glycemic index. The glycemic index is a scale that measures how much a certain carbohydrate causes a person's blood sugar to rise. A low glycemic load diet may help decrease the chance of cancer coming back and improve the survival in patients with colon cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility of following a low or medium glycemic load diet in patients with stage I-III (local-regional) colon cancer.
SECONDARY OBJECTIVES:
I. To determine patient-reported acceptability of diet. II. To determine nutritionist resources utilized. III. To evaluate the effect of lowering dietary glycemic load on body mass index (BMI), lipid metabolism and pro-oncogenic intermediaries of cellular metabolism.
OUTLINE: Patients are sequentially enrolled in 1 of 4 possible cohorts as needed based on the feasibility of the prior cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Patients must have stage I-III colon or rectal cancer and have undergone definitive therapy; definitive therapy may have included surgery alone, or surgery plus neoadjuvant and/or adjuvant therapy
- •Patients must regularly consume a diet with a glycemic load > 150 as estimated through the 3 day food recall
- •Patients must readily be available for a 3 month period and agree to participate in regular dietary adherence assessments (surveys and phone interviews)
排除标准
- •Current participation in an intervention targeting diet or exercise
研究组 & 干预措施
Cohort 1: Low glycemic load with standard diet
Patients follow a low glycemic load diet with a standard dietary intervention for 12 weeks.
干预措施: questionnaire administration (Other)
Cohort 1: Low glycemic load with standard diet
Patients follow a low glycemic load diet with a standard dietary intervention for 12 weeks.
干预措施: Standard Dietary Intervention (Behavioral)
Cohort 1: Low glycemic load with standard diet
Patients follow a low glycemic load diet with a standard dietary intervention for 12 weeks.
干预措施: Low glycemic load (Behavioral)
Cohort 2: Low glycemic load with intensified diet
Patients follow a low glycemic load diet with intensified dietary intervention for 12 weeks.
干预措施: questionnaire administration (Other)
Cohort 2: Low glycemic load with intensified diet
Patients follow a low glycemic load diet with intensified dietary intervention for 12 weeks.
干预措施: laboratory biomarker analysis (Other)
Cohort 2: Low glycemic load with intensified diet
Patients follow a low glycemic load diet with intensified dietary intervention for 12 weeks.
干预措施: Intensified Dietary Intervention (Behavioral)
Cohort 2: Low glycemic load with intensified diet
Patients follow a low glycemic load diet with intensified dietary intervention for 12 weeks.
干预措施: Low glycemic load (Behavioral)
Cohort 3: Medium glycemic load with standard diet
Patients follow a medium glycemic load diet with standard dietary intervention for 12 weeks.
干预措施: questionnaire administration (Other)
Cohort 3: Medium glycemic load with standard diet
Patients follow a medium glycemic load diet with standard dietary intervention for 12 weeks.
干预措施: laboratory biomarker analysis (Other)
Cohort 3: Medium glycemic load with standard diet
Patients follow a medium glycemic load diet with standard dietary intervention for 12 weeks.
干预措施: Standard Dietary Intervention (Behavioral)
Cohort 3: Medium glycemic load with standard diet
Patients follow a medium glycemic load diet with standard dietary intervention for 12 weeks.
干预措施: Medium Glycemic Load (Behavioral)
Cohort 4: Medium glycemic load with intensified diet
Patients follow a medium glycemic load diet with intensified dietary intervention for 12 weeks.
干预措施: questionnaire administration (Other)
Cohort 4: Medium glycemic load with intensified diet
Patients follow a medium glycemic load diet with intensified dietary intervention for 12 weeks.
干预措施: laboratory biomarker analysis (Other)
Cohort 4: Medium glycemic load with intensified diet
Patients follow a medium glycemic load diet with intensified dietary intervention for 12 weeks.
干预措施: Intensified Dietary Intervention (Behavioral)
Cohort 4: Medium glycemic load with intensified diet
Patients follow a medium glycemic load diet with intensified dietary intervention for 12 weeks.
干预措施: Medium Glycemic Load (Behavioral)
结局指标
主要结局
Individual patient compliance, defined by following assigned target glycemic load index >= 75% of the time between weeks 4 and 12
时间窗: Up to week 12
This compliance rate will be determined through conducting a 24 hour telephone recall, every 2 weeks at random and calculating the glycemic load. For each dose cohort, the number and percentage of patients who are compliant will be summarized, with 90% confidence interval that accounts for the two-stage design.
次要结局
- Hours of nutritionist time per week(Up to 12 weeks)
- Food acceptability score(Up to 12 weeks)