Nutrition Support to Improve Outcomes in Patients With Unresectable Pancreatic Cancer

Study Overview
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Brief Summary
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There are few well-designed studies evaluating the effect of nutrition support in patients with cancer cachexia. The aim of this study is to examine the effect of dietary prescription with and without nutrition supplementation in patients with unresectable pancreatic cancer on body weight, body composition, total calorie intake, quality of life and blood inflammatory markers.

Detailed Description
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A total of 60 subjects will be recruited from The University of California Los Angeles (UCLA) Hirshberg Pancreatic Cancer Center, print and/or radio advertisements, UCLA campus wide e-mail, and flyers posted on campus and in the community. Participants will be pre-screened over the telephone to determine eligibility. Eligible subjects will be asked to come to the Center for Human Nutrition for a Screening Visit. At screening, informed consent and authorization will be reviewed and signed a medical history will be obtained. The subjects will be screened by medical history/physical exam, a fasting blood sample will be collected for a comprehensive metabolic panel, a complete blood count, chemistry and liver function tests. Day 1 will be the first study day. Subjects will come to the UCLA Center for Human Nutrition in the fasting state and remain for approximately  1 hour. The food intake record will be collected and entered into the Automated Self- Administered Food Recall (NIH ASA24). The vital signs, anthropometric assessments will be measured and quality of life questionnaire will be completed. A fasting blood sample (20 ml) will be collected for metabolic panel and inflammatory markers. A 6-minute walk will be done at the research center. Subjects will be evaluated by a registered dietitian and randomized to diet prescription (55% carbohydrate, 30% fat and 15% protein) vs. the same diet prescription including three servings of supplement powder and fish oil. The research dietitian will develop meal plans based on basal metabolic rate and physical activity. Subjects will be provided a pedometer to wear daily. Any subject in either group who develops symptoms of pancreatic insufficiency will be provided with pancreatic enzyme supplementation. Day 28, 56, 84 and 112 will be follow-up visits. The same procedures will be performed as on day 1. Subjects will come to the UCLA Center for Human Nutrition in the fasting state and remain for approximately  1 hour.

Official Title
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Nutrition Support to Improve Outcomes in Patients With Unresectable Pancreatic Cancer

Conditions
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Cancer of Pancreas

Intervention / Treatment
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* Dietary Supplement: Nutrawell Powder
* Other: Diet Only
* Dietary Supplement: OmegaRich fish oil supplement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unresectable pancreatic adenocarcinoma Weight loss of greater than 5% in the previous 6 months Life expectancy of greater than 3 months and a Karnofsky performance score of 60 or more. Non-smokers Exclusion Criteria: Chemotherapy other than gemcitabine Radiotherapy, or surgical treatment in the previous month Consumption of dietary supplements or medications such as steroids that could affect metabolism. Presence of ascites Liver function test > 2 standard deviation of upper limit Chronic or acute renal insufficiency Severe anemia with hemoglobin<10 Uncontrolled pain Uncontrolled nausea and vomiting Participation in a therapeutic research study within 30 days of baseline Diet restrictions including vegetarianism and veganism Allergy or intolerance to fish and/or fish oil

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diet + Nutrawell Powder with Fish Oil<br>Subjects will be evaluated by a registered dietitian with a diet prescription (55% carbohydrate, 30% fat and 15% protein) including Nutrawell powder with fish oil. | Dietary Supplement: Nutrawell Powder<br>* The NutraWell nutrition powder will be provided by and distributed from New Health Nutraceuticals (Irvine, California - USA). Nutrawell is manufactured New Health Enterprises, Inc. The supplement sample will be stored at room temperature in the UCLA Center for Human Nutrition research unit. OmegaRich Contains high concentration and high purity of natural omega-3 polyunsaturated fatty acids: Eicosapenatenoic acid (EPA) and docosahexaenoic acid (DHA) from deep water fish. Enriched with natural vitamin E: d- tocopherol Triglyceride form (TG-form) of the raw fish oil ingredients. Each fish oil capsule contains 55% EPA and DHA with 330 mg EPA and 220 mg DHA.<br>Dietary Supplement: OmegaRich fish oil supplement<br>* OmegaRich is manufactured New Health Enterprises, Inc. The supplement sample will be stored at room temperature in the UCLA Center for Human Nutrition research unit. OmegaRich Contains: high concentration and high purity of natural omega-3 polyunsaturated fatty acids: Eicosapenatenoic acid (EPA) and docosahexaenoic acid (DHA) from deep water fish. Enriched with natural vitamin E: d- tocopherol Triglyceride form (TG-form) of the raw fish oil ingredients. Each fish oil capsule contains 55% EPA and DHA with 330 mg EPA and 220 mg DHA.<br>|
| Active Comparator: Dietary Intervention Only<br>Subjects will be evaluated by a registered dietitian with a diet prescription (55% carbohydrate, 30% fat and 15% protein) not including servings of Nutrawell powder with fish oil. | Other: Diet Only<br>* Subjects will be evaluated by a registered dietitian and randomized to diet prescription (55% carbohydrate, 30% fat and 15% protein)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric measurement: Weight | Weight in Kilograms | At each visit outlined for 3 months | 
| Anthropometric measurement: Body Composition | Body Composition: kilogram weight of lean body mass | At each visit outlined for 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood biochemistry | complete blood count | At each visit outlined for 3 months | 
| Blood biochemistry | Blood electrolytes | At each visit outlined for 3 months | 
| Blood biochemistry | Liver function test | At each visit outlined for 3 months | 
| Blood biochemistry | Lipid panel | At each visit outlined for 3 months | 
| Blood biochemistry | Pancreatic tumor markers | At each visit outlined for 3 months | 
| Blood biochemistry | Inflammatory markers | At each visit outlined for 3 months | 
| Physical activity | All subjects will be provided a pedometer to record daily steps. | At each visit outlined for 3 months | 
| Physical activity | A 6 minute walk will be done at each visit. | At each visit outlined for 3 months | 
| Physical activity | Karnofsky performance score | At each visit outlined for 3 months | 
| Quality of life: General | Measured with short form health survey (SF36) | At each visit outlined for 3 months | 
| Quality of life: Appetite | Appetite will be measured on a numerical rating scale between 0 and 10, where 0 indicated absolutely no appetite and 10 indicated an extremely good appetite (Simons et al, 1996) | At each visit outlined for 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Food, and Nutrition