Low Glycemic Load Diet in Patients With Stage I-III Colon Cancer
A Pilot Study to Determine the Feasibility of a Low Glycemic Load Diet in Patients With Stage I-III Colon Cancer
3 other identifiers
interventional
18
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2015
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2014
CompletedFirst Posted
Study publicly available on registry
May 2, 2014
CompletedStudy Start
First participant enrolled
February 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2018
CompletedJuly 20, 2018
July 1, 2018
3.3 years
April 17, 2014
July 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Food acceptability score
Up to 12 weeks
Hours of nutritionist time per week
Up to 12 weeks
Other Outcomes (4)
Change in serum levels of glycosylated hemoglobin
Baseline to up to 12 weeks
Change in BMI
Baseline to up to 12 weeks
Change in serum levels of markers of lipid metabolism
Baseline to up to 12 weeks
- +1 more other outcomes
Study Arms (4)
Cohort 1: Low glycemic load with standard diet
EXPERIMENTALPatients follow a low glycemic load diet with a standard dietary intervention for 12 weeks.
Cohort 2: Low glycemic load with intensified diet
EXPERIMENTALPatients follow a low glycemic load diet with intensified dietary intervention for 12 weeks.
Cohort 3: Medium glycemic load with standard diet
ACTIVE COMPARATORPatients follow a medium glycemic load diet with standard dietary intervention for 12 weeks.
Cohort 4: Medium glycemic load with intensified diet
ACTIVE COMPARATORPatients follow a medium glycemic load diet with intensified dietary intervention for 12 weeks.
Interventions
Ancillary studies including three day food record, twenty-four hour dietary recall, and a food acceptability questionnaire.
Correlative studies
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).
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Current participation in an intervention targeting diet or exercise
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Case Comprehensive Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065, United States
Metrohealth Medical Center
Cleveland, Ohio, 44106, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michelle Treasure, MD
Case Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2014
First Posted
May 2, 2014
Study Start
February 16, 2015
Primary Completion
June 14, 2018
Study Completion
July 10, 2018
Last Updated
July 20, 2018
Record last verified: 2018-07