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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00831 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CASE7213 | Other Identifier | Case Comprehensive Cancer Center | |
| P30CA043703 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Low glycemic load with standard diet | Experimental | Patients follow a low glycemic load diet with a standard dietary intervention for 12 weeks. |
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| Cohort 2: Low glycemic load with intensified diet | Experimental | Patients follow a low glycemic load diet with intensified dietary intervention for 12 weeks. |
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| Cohort 3: Medium glycemic load with standard diet | Active Comparator | Patients follow a medium glycemic load diet with standard dietary intervention for 12 weeks. |
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| Cohort 4: Medium glycemic load with intensified diet | Active Comparator | Patients follow a medium glycemic load diet with intensified dietary intervention for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| questionnaire administration | Other | Ancillary studies including three day food record, twenty-four hour dietary recall, and a food acceptability questionnaire. |
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| 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 |
| 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 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Treasure, MD | Case Comprehensive Cancer Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Comprehensive Cancer Center | Cleveland | Ohio | 44106-5065 | United States | ||
| Metrohealth Medical Center |
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| laboratory biomarker analysis | Other | Correlative studies |
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| Standard Dietary Intervention | Behavioral | 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). |
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| Intensified Dietary Intervention | Behavioral | 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. |
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| Low glycemic load | Behavioral |
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| Medium Glycemic Load | Behavioral |
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The median number of hours will be calculated based on time spent with each patient, separately for each cohort.
| Up to 12 weeks |
| 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 |
| Cleveland |
| Ohio |
| 44106 |
| United States |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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