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

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Stage III Rectal Cancer; Stage II Colon Cancer; Stage II Rectal Cancer; Stage III Colon Cancer; Stage I Colon Cancer; Stage I Rectal Cancer

Treatments: Behavioral: Low glycemic load; Behavioral: Intensified Dietary Intervention; Other: laboratory biomarker analysis; Other: questionnaire administration; Behavioral: Medium Glycemic Load; Behavioral: Standard Dietary Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02129218

P30CA043703 (U.S. NIH Grant/Contract)

CASE7213 (Other Identifier)

NCI-2014-00831 (Registry Identifier)

Details and patient eligibility

About

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.

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 4 patient groups

Cohort 1: Low glycemic load with standard diet

Experimental group

Description:

Patients follow a low glycemic load diet with a standard dietary intervention for 12 weeks.

Treatment:

Behavioral: Low glycemic load

Behavioral: Standard Dietary Intervention

Other: questionnaire administration

Cohort 2: Low glycemic load with intensified diet

Experimental group

Description:

Patients follow a low glycemic load diet with intensified dietary intervention for 12 weeks.

Treatment:

Behavioral: Low glycemic load

Behavioral: Intensified Dietary Intervention

Other: questionnaire administration

Other: laboratory biomarker analysis

Cohort 3: Medium glycemic load with standard diet

Active Comparator group

Description:

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

Treatment:

Behavioral: Medium Glycemic Load

Behavioral: Standard Dietary Intervention

Other: questionnaire administration

Other: laboratory biomarker analysis

Cohort 4: Medium glycemic load with intensified diet

Active Comparator group

Description:

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

Treatment:

Behavioral: Medium Glycemic Load

Behavioral: Intensified Dietary Intervention

Other: questionnaire administration

Other: laboratory biomarker analysis