Clinical trial NCT02129218: Low Glycemic Load Diet in Patients With Stage I-III Colon Cancer
Official title: A Pilot Study to Determine the Feasibility of a Low Glycemic Load Diet in Patients With Stage I-III Colon Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stage I Colon Cancer
Stage II Colon Cancer
Stage III Colon Cancer
Stage I Rectal Cancer
Stage II Rectal Cancer
Stage III Rectal Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-05-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Individual patient compliance, defined by following assigned target glycemic load index >= 75% of the time between weeks 4 and 12
timeFrame: Up to week 12
Secondary outcomes:
measure: Food acceptability score
timeFrame: Up to 12 weeks
measure: Hours of nutritionist time per week
timeFrame: Up to 12 weeks
Other outcomes:
measure: Change in serum levels of glycosylated hemoglobin
timeFrame: Baseline to up to 12 weeks
measure: Change in BMI
timeFrame: Baseline to up to 12 weeks
measure: Change in serum levels of markers of lipid metabolism
timeFrame: Baseline to up to 12 weeks
measure: Change in serum levels of proteins affected by carbohydrate metabolism
timeFrame: Baseline to up to 12 weeks
Locations:
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Metrohealth Medical Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Michelle Treasure, MD
role: STUDY_DIRECTOR
References: