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

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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

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.

Condition or disease Intervention/treatment Phase
Stage I Colon Cancer Stage II Colon Cancer Stage III Colon Cancer Stage I Rectal Cancer Stage II Rectal Cancer Stage III Rectal Cancer Other: questionnaire administration Other: laboratory biomarker analysis Behavioral: Standard Dietary Intervention Behavioral: Intensified Dietary Intervention Behavioral: Low glycemic load Behavioral: Medium Glycemic Load Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study to Determine the Feasibility of a Low Glycemic Load Diet in Patients With Stage I-III Colon Cancer
Actual Study Start Date : February 16, 2015
Actual Primary Completion Date : June 14, 2018
Actual Study Completion Date : July 10, 2018

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: 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: 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
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: 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: 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: 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: 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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129218


Locations
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United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Metrohealth Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Study Director: Michelle Treasure, MD Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02129218     History of Changes
Other Study ID Numbers: CASE7213
NCI-2014-00831 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE7213 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Rectal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases