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NCT Number: NCT02129218

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.

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Key information

Conditions

Stage I Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms Stage I Rectal Cancer Stage II Colon Cancer Stage II Rectal Cancer Stage III Colon Cancer Stage III Rectal Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Comprehensive Cancer Center, Cleveland, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Administration

Other

Ancillary studies including three day food record, twenty-four hour dietary recall, and a food acceptability questionnaire.

laboratory biomarker analysis

Other

Correlative studies

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).

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.

Low glycemic load

Behavioral

Medium Glycemic Load

Behavioral

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 2, 2014
Registry last updated
Jul 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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