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

Stage III Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02129218
• Other study ID #: CASE7213
• Secondary ID: NCI-2014-00831CA
• Status: Completed
• Phase: N/A
• Start date: February 16, 2015
• Est. completion date: July 10, 2018

Study information

• Verified date: July 2018
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 10, 2018
• Est. primary completion date: June 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonic Neoplasms
• Rectal Neoplasms
• 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

Other:
• questionnaire administration
Ancillary studies including three day food record, twenty-four hour dietary recall, and a food acceptability questionnaire.
• 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).
• 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.
• Low glycemic load

• Medium Glycemic Load

Locations

Country	Name	City	State
United States	Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Metrohealth Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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