Cancer of Pancreas
Conditions
Keywords
Diet, Food, and Nutrition
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTNutrawell Powder
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.
OTHERDiet Only
Subjects will be evaluated by a registered dietitian and randomized to diet prescription (55% carbohydrate, 30% fat and 15% protein)
DIETARY_SUPPLEMENTOmegaRich fish oil supplement
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.
Sponsors
Do Well Laboratories Inc.
Hirshberg Foundation for Pancreatic Cancer Research
Jonsson Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anthropometric measurement: Weight | At each visit outlined for 3 months | Weight in Kilograms |
| Anthropometric measurement: Body Composition | At each visit outlined for 3 months | Body Composition: kilogram weight of lean body mass |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood biochemistry | At each visit outlined for 3 months | complete blood count |
| Physical activity | At each visit outlined for 3 months | All subjects will be provided a pedometer to record daily steps. |
| Quality of life: General | At each visit outlined for 3 months | Measured with short form health survey (SF36) |
| Quality of life: Appetite | At each visit outlined for 3 months | 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) |
Countries
United States
Outcome results
None listed