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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-5065
      • Case Comprehensive Cancer Center
    • Cleveland, Ohio, United States, 44106
      • MetroHealth Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Low glycemic load with standard diet; Patients follow a low glycemic load diet with a standard dietary intervention for 12 weeks.	Other: questionnaire administration; Ancillary studies including three day food record, twenty-four hour dietary recall, and a food acceptability questionnaire.; 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: Low glycemic load
Experimental: Cohort 2: Low glycemic load with intensified diet; Patients follow a low glycemic load diet with intensified dietary intervention for 12 weeks.	Other: laboratory biomarker analysis; Correlative studies; Other: questionnaire administration; Ancillary studies including three day food record, twenty-four hour dietary recall, and a food acceptability questionnaire.; Behavioral: Low glycemic load; 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.
Active Comparator: Cohort 3: Medium glycemic load with standard diet; Patients follow a medium glycemic load diet with standard dietary intervention for 12 weeks.	Other: laboratory biomarker analysis; Correlative studies; Other: questionnaire administration; Ancillary studies including three day food record, twenty-four hour dietary recall, and a food acceptability questionnaire.; 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: Medium Glycemic Load
Active Comparator: Cohort 4: Medium glycemic load with intensified diet; Patients follow a medium glycemic load diet with intensified dietary intervention for 12 weeks.	Other: laboratory biomarker analysis; Correlative studies; Other: questionnaire administration; Ancillary studies including three day food record, twenty-four hour dietary recall, and a food acceptability questionnaire.; 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: Medium Glycemic Load

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Individual patient compliance, defined by following assigned target glycemic load index >= 75% of the time between weeks 4 and 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.	Up to week 12

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum levels of glycosylated hemoglobin	Separately for each cohort, serum levels will be summarized descriptively and graphically across the follow-up period. Paired t-tests or Wilcoxon signed rank tests will be used to compare baseline vs. post-intervention levels of all biomarkers. Changes in biomarkers will be correlated with dietary glycemic index (GI) using Pearson or Spearman correlation coefficients, across the follow-up period.	Baseline to up to 12 weeks
Change in BMI	Separately for each cohort, BMI levels will be summarized descriptively and graphically across the follow-up period.	Baseline to up to 12 weeks
Change in serum levels of markers of lipid metabolism	Separately for each cohort, serum levels will be summarized descriptively and graphically across the follow-up period. Paired t-tests or Wilcoxon signed rank tests will be used to compare baseline vs. post-intervention levels of all biomarkers. Changes in biomarkers will be correlated with dietary GI using Pearson or Spearman correlation coefficients, across the follow-up period.	Baseline to up to 12 weeks
Change in serum levels of proteins affected by carbohydrate metabolism	Separately for each cohort, serum levels will be summarized descriptively and graphically across the follow-up period. Paired t-tests or Wilcoxon signed rank tests will be used to compare baseline vs. post-intervention levels of all biomarkers. Changes in biomarkers will be correlated with dietary GI using Pearson or Spearman correlation coefficients, across the follow-up period.	Baseline to up to 12 weeks

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Director: Michelle Treasure, MD, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2015
• Primary Completion (Actual): June 14, 2018
• Study Completion (Actual): July 10, 2018

Study Registration Dates

• First Submitted: April 17, 2014
• First Submitted That Met QC Criteria: April 30, 2014
• First Posted (Estimate): May 2, 2014

Study Record Updates

• Last Update Posted (Actual): July 20, 2018
• Last Update Submitted That Met QC Criteria: July 19, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: CASE7213 (Other Identifier: Case Comprehensive Cancer Center); P30CA043703 (U.S. NIH Grant/Contract); NCI-2014-00831 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No