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



Status:Completed
Conditions:Colorectal Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/22/2018
Start Date:February 16, 2015
End Date:July 10, 2018

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A Pilot Study to Determine the Feasibility of a Low Glycemic Load Diet in Patients With Stage I-III Colon Cancer

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.

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.

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
We found this trial at
2
sites
2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
Phone: 216-845-0310
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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11100 Euclid Avenue
Cleveland, Ohio 44106
216.844.8797
Principal Investigator: Neal Meropol
Phone: 216-844-5220
Case Comprehensive Cancer Center The Case Comprehensive Cancer Center (Case CCC) based at Case Western...
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Cleveland, OH
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