NCT02129218

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stage I Colon Cancer
• Stage II Colon Cancer
• Stage III Colon Cancer
• Stage I Rectal Cancer
• Stage II Rectal Cancer
• Stage III Rectal Cancer

Interventions

Type	Name	Description
OTHER	questionnaire administration	Ancillary studies including three day food record, twenty-four hour dietary recall, and a food acceptability questionnaire.
OTHER	laboratory biomarker analysis	Correlative studies
BEHAVIORAL	Standard Dietary Intervention	Participants will be contacted by a nutritionist, in person every 2 weeks with phone contact on the alternating weeks. At the initial visit, each participant will be given verbal and written patient education materials, including low glycemic load diet recipes, meal plans, food preparation, and grocery shopping information. Individual instruction will be tailored to their baseline dietary preferences (e.g. vegan, allergies, etc).
BEHAVIORAL	Intensified Dietary Intervention	Patients will be contacted weekly, in person, by a nutritionist . Participants will take part in a cooking demonstration at the time of their initial visit. The demonstration will be hands-on and participants will be able to sample foods and recipes. In addition to grocery shopping information, participants will be accompanied by a nutritionist to their local grocery store to practice new shopping habits for their target dietary glycemic load. Each participant will also receive weekly random phone calls to assess his or her progress.
BEHAVIORAL	Low glycemic load
BEHAVIORAL	Medium Glycemic Load

Timeline

• Start date: 2015-02-16
• Primary completion: 2018-06-14
• Completion: 2018-07-10
• First posted: 2014-05-02
• Last updated: 2018-07-20

Locations

2 sites across 1 country: United States