Clinical trial NCT03489213: Nutrition and Exercise Trial: Improving Diet and Physical Activity Patterns in Overweight Cancer Survivors
Official title: NExT (Nutrition and Exercise Cancer Survivor Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivor
Overweight
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized phase II trial will enroll overweight cancer survivors. Subjects in both groups will be educated to follow a diet pattern similar to what is recommended by the Dietary Guidelines for Americans and the American Institute for Cancer Research (DGA/AICR) but one group will also receive 18 ounces of lean beef for incorporation into a healthy diet. Subjects will be encouraged to exercise regularly and activity will be monitored throughout the study. Nutrition and exercise may help cancer survivors successfully maintain improved dietary patterns, body composition, and physical activity efforts and consumption of beef may favorably impact lean body mass and specific nutritional outcomes.

Detailed description: PRIMARY OBJECTIVES:

I. To determine the feasibility and compliance with a the Dietary Guidelines for Americans/American Institute for Cancer Research (DGA/AICR) healthy dietary pattern and a beef + DGA/AICR healthy dietary pattern in cancer survivors.

II. To determine the impact of dietary interventions on body composition, clinical outcomes, and physical performance.

III. To quantify the impact of the two dietary interventions on cardiometabolic biomarkers of health.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive DGA/AICR-based dietary intervention for 6 months consisting of 12 education sessions over 60 minutes every other week, fruit, vegetable, and herb harvesting 1-2 times per week for 2 hours, wearing a FitBit during physical activity, and remote health coaching over 10 minutes for 12 weeks.

ARM II: Patients receive DGA/AICR-based dietary intervention as in Arm I and consume 11-18 ounces of lean beef each week for 6 months.

Clinical and physical activity assessments will take place at baseline, after the intervention and at 12 months.

Eligibility criteria: Inclusion Criteria:

* Have a body mass index (BMI) \>= 25 kg/m\^2
* Be non-vegetarian/non-vegan, and have no concerns with beef consumption
* Have completed active curative therapy for cancer within the past 36 months (i.e., surgery, chemotherapy, or radiation); ongoing hormone therapy is acceptable
* Voluntarily provide consent, Health Insurance Portability and Accountability Act (HIPPA) authorization form, and consent from primary care provider (PCP) or treating oncologist
* Not be planning to travel for more than 3 consecutive weeks during the intervention period
* Agree to refrain from all nutritional supplements, herbal supplements, and botanical supplements aside from those prescribed by a physician for the duration of the study

Exclusion Criteria:

* Are cognitively unable to consent or have physical or mental limitations that would prevent full participation in the program
* Are vegan or those unwilling to consume 11-18 ounces (oz) of beef per week
* Have pre-existing medical conditions that preclude unsupervised physical activity (i.e., severe orthopedic conditions, impending hip or knee replacement, paralysis, unstable angina, dementia, recent history of myocardial infarction, congestive heart failure, pulmonary conditions requiring oxygen, or hospitalization in past 6 months)
* Have had cancer treatment that significantly impacts digestion, metabolism, or food intake (e.g., surgical loss of esophagus, stomach, or colon, pancreas dysfunction, or brain surgery that alters cognition, etc.)
* Report meeting the recommendations for physical activity (\> 60 minutes per day, most days per week) and already meet the majority of dietary guidelines as assessed by a telephone screener
* Are prescribed medication that do not allow for increased intake of fruits and vegetables
* Have recently (\< 3 months) started a statin or other lipid lowering medication; participants who report that they are changing a lipid lowering drug dose or drug type during the recruitment period will also be excluded; participants who have been stable on a lipid-lowering medication for at least 3 months may participate; well-controlled diabetics (type I or II) may participate
* Have been diagnosed with active metabolic or digestive illnesses (i.e., Celiac disease, irritable bowel syndrome \[IBS\], renal insufficiency, hepatic insufficiency)
* Are pregnant or are planning to become pregnant during the study

Primary outcomes:
measure: Adherence to either the DGA/AICR group or the DGA/AICR + Beef group
timeFrame: Up to 12 months
measure: Change in body composition
timeFrame: Up to 12 months
measure: Change in blood pressure
timeFrame: Baseline up to 12 months
measure: Change in body mass index (BMI)
timeFrame: Baseline up to 12 months
measure: Change in dietary carotenoid intake
timeFrame: Baseline up to 12 months
measure: Change in blood carotenoids
timeFrame: Up to 12 months
measure: Change in physical performance assessed by timed performance-related mobility tasks
timeFrame: Baseline up to 12 months
measure: Change in physical performance
timeFrame: Up to 12 months
measure: Dietary intake patterns
timeFrame: Up to 6 months
measure: Adherence to classes
timeFrame: Up to 12 months
measure: Change in fasting glucose
timeFrame: Up to 12 months
measure: Change in lipoprotein profiles
timeFrame: Up to 12 months
measure: Daily physical activity (steps per day)
timeFrame: up to 12 months
Secondary outcomes:
measure: Health related quality of life
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Steven Clinton, MD
role: PRINCIPAL_INVESTIGATOR
References: