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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02129218
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : July 20, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE April 17, 2014
First Posted Date  ICMJE May 2, 2014
Last Update Posted Date July 20, 2018
Actual Study Start Date  ICMJE February 16, 2015
Actual Primary Completion Date June 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2014)
Individual patient compliance, defined by following assigned target glycemic load index >= 75% of the time between weeks 4 and 12 [ Time Frame: Up to week 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02129218 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2014)
  • Food acceptability score [ Time Frame: Up to 12 weeks ]
    Results of the acceptability survey will be tabulated and described (the questions use a 7 point likert scale), separately for each cohort.
  • Hours of nutritionist time per week [ Time Frame: Up to 12 weeks ]
    The median number of hours will be calculated based on time spent with each patient, separately for each cohort.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 30, 2014)
  • Change in serum levels of glycosylated hemoglobin [ Time Frame: Baseline to up to 12 weeks ]
    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.
  • Change in BMI [ Time Frame: Baseline to up to 12 weeks ]
    Separately for each cohort, BMI levels will be summarized descriptively and graphically across the follow-up period.
  • Change in serum levels of markers of lipid metabolism [ Time Frame: Baseline to up to 12 weeks ]
    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.
  • Change in serum levels of proteins affected by carbohydrate metabolism [ Time Frame: Baseline to up to 12 weeks ]
    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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Low Glycemic Load Diet in Patients With Stage I-III Colon Cancer
Official Title  ICMJE A Pilot Study to Determine the Feasibility of a Low Glycemic Load Diet in Patients With Stage I-III Colon Cancer
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Stage I Colon Cancer
  • Stage II Colon Cancer
  • Stage III Colon Cancer
  • Stage I Rectal Cancer
  • Stage II Rectal Cancer
  • Stage III Rectal Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Cohort 1: Low glycemic load with standard diet
    Patients follow a low glycemic load diet with a standard dietary intervention for 12 weeks.
    Interventions:
    • Other: questionnaire administration
    • Behavioral: Standard Dietary Intervention
    • 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.
    Interventions:
    • Other: questionnaire administration
    • Other: laboratory biomarker analysis
    • Behavioral: Intensified Dietary Intervention
    • Behavioral: Low glycemic load
  • Active Comparator: Cohort 3: Medium glycemic load with standard diet
    Patients follow a medium glycemic load diet with standard dietary intervention for 12 weeks.
    Interventions:
    • Other: questionnaire administration
    • Other: laboratory biomarker analysis
    • Behavioral: Standard Dietary Intervention
    • 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.
    Interventions:
    • Other: questionnaire administration
    • Other: laboratory biomarker analysis
    • Behavioral: Intensified Dietary Intervention
    • Behavioral: Medium Glycemic Load
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2018)
18
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2014)
72
Actual Study Completion Date  ICMJE July 10, 2018
Actual Primary Completion Date June 14, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02129218
Other Study ID Numbers  ICMJE CASE7213
NCI-2014-00831 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE7213 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Case Comprehensive Cancer Center
Study Sponsor  ICMJE Case Comprehensive Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Director: Michelle Treasure, MD Case Comprehensive Cancer Center
PRS Account Case Comprehensive Cancer Center
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP