Low Glycemic Load Diet in Patients With Stage I-III Colon Cancer

Not Applicable

Completed

• Conditions: Stage I Colon Cancer; Stage III Colon Cancer; Stage I Rectal Cancer; Stage II Colon Cancer; Stage II Rectal Cancer; Stage III Rectal Cancer
• Interventions: Other: questionnaire administration; Behavioral: Standard Dietary Intervention; Other: laboratory biomarker analysis; Behavioral: Low glycemic load; Behavioral: Intensified Dietary Intervention; Behavioral: Medium Glycemic Load

• Registration Number: NCT02129218
• Lead Sponsor: Case Comprehensive Cancer Center

Brief Summary

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.

Detailed Description

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.

COHORT 1: Patients follow a low glycemic load diet with standard dietary intervention (contact with nutritionist in person every 2 weeks with phone contact on the alternating weeks) for 12 weeks.

COHORT 2: Patients follow a low glycemic load diet with intensified dietary intervention (contact with nutritionist in person every week) for 12 weeks.

COHORT 3: Patients follow a medium glycemic load diet with standard dietary intervention for 12 weeks.

COHORT 4: Patients follow a medium glycemic load diet with intensified dietary intervention for 12 weeks.

Study Timeline

• Study First Submitted: 2014-04-17
• Study First Submitted QC: 2014-04-30
• Study First Posted: 2014-05-02
• Study Start: 2015-02-16
• Primary Completion: 2018-06-14
• Status Verified: 2018-07
• Study Completion: 2018-07-10
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• 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)

Exclusion Criteria

• Current participation in an intervention targeting diet or exercise

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: Low glycemic load with standard diet	Standard Dietary Intervention	Patients follow a low glycemic load diet with a standard dietary intervention for 12 weeks.
Cohort 2: Low glycemic load with intensified diet	laboratory biomarker analysis	Patients follow a low glycemic load diet with intensified dietary intervention for 12 weeks.
Cohort 1: Low glycemic load with standard diet	Low glycemic load	Patients follow a low glycemic load diet with a standard dietary intervention for 12 weeks.
Cohort 3: Medium glycemic load with standard diet	laboratory biomarker analysis	Patients follow a medium glycemic load diet with standard dietary intervention for 12 weeks.
Cohort 2: Low glycemic load with intensified diet	Low glycemic load	Patients follow a low glycemic load diet with intensified dietary intervention for 12 weeks.
Cohort 1: Low glycemic load with standard diet	questionnaire administration	Patients follow a low glycemic load diet with a standard dietary intervention for 12 weeks.
Cohort 2: Low glycemic load with intensified diet	questionnaire administration	Patients follow a low glycemic load diet with intensified dietary intervention for 12 weeks.
Cohort 2: Low glycemic load with intensified diet	Intensified Dietary Intervention	Patients follow a low glycemic load diet with intensified dietary intervention for 12 weeks.
Cohort 3: Medium glycemic load with standard diet	Medium Glycemic Load	Patients follow a medium glycemic load diet with standard dietary intervention for 12 weeks.
Cohort 4: Medium glycemic load with intensified diet	questionnaire administration	Patients follow a medium glycemic load diet with intensified dietary intervention for 12 weeks.
Cohort 4: Medium glycemic load with intensified diet	laboratory biomarker analysis	Patients follow a medium glycemic load diet with intensified dietary intervention for 12 weeks.
Cohort 4: Medium glycemic load with intensified diet	Medium Glycemic Load	Patients follow a medium glycemic load diet with intensified dietary intervention for 12 weeks.
Cohort 3: Medium glycemic load with standard diet	questionnaire administration	Patients follow a medium glycemic load diet with standard dietary intervention for 12 weeks.
Cohort 4: Medium glycemic load with intensified diet	Intensified Dietary Intervention	Patients follow a medium glycemic load diet with intensified dietary intervention for 12 weeks.
Cohort 3: Medium glycemic load with standard diet	Standard Dietary Intervention	Patients follow a medium glycemic load diet with standard dietary intervention for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Individual patient compliance, defined by following assigned target glycemic load index >= 75% of the time between weeks 4 and 12	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.

Secondary Outcome Measures

Name	Time	Method
Hours of nutritionist time per week	Up to 12 weeks	The median number of hours will be calculated based on time spent with each patient, separately for each cohort.
Food acceptability score	Up to 12 weeks	Results of the acceptability survey will be tabulated and described (the questions use a 7 point likert scale), separately for each cohort.

Trial Locations

Locations (2)

Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States

Metrohealth Medical Center; 🇺🇸 Cleveland, Ohio, United States