Colon Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Colon Cancer

Estimated Enrollment:

18

Study ID:

NCT02129218

Recruitment Status:

Completed

Sponsor:

Case Comprehensive Cancer Center

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There is 1 Location for this study

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Case Comprehensive Cancer Center
Cleveland Ohio, 44106, United States
Metrohealth Medical Center
Cleveland Ohio, 44106, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

18

Study ID:

NCT02129218

Recruitment Status:

Completed

Sponsor:


Case Comprehensive Cancer Center

How clear is this clinincal trial information?

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