Clinical trial NCT02681601: Nutrition Support to Improve Outcomes in Patients With Unresectable Pancreatic Cancer
Official title: Nutrition Support to Improve Outcomes in Patients With Unresectable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer of Pancreas
Keywords: Diet, Food, and Nutrition
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Do Well Laboratories Inc.
name: Hirshberg Foundation for Pancreatic Cancer Research
First posted: 2016-02-12
Enrollment: 2
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anthropometric measurement: Weight
timeFrame: At each visit outlined for 3 months
measure: Anthropometric measurement: Body Composition
timeFrame: At each visit outlined for 3 months
Secondary outcomes:
measure: Blood biochemistry
timeFrame: At each visit outlined for 3 months
measure: Blood biochemistry
timeFrame: At each visit outlined for 3 months
measure: Blood biochemistry
timeFrame: At each visit outlined for 3 months
measure: Blood biochemistry
timeFrame: At each visit outlined for 3 months
measure: Blood biochemistry
timeFrame: At each visit outlined for 3 months
measure: Blood biochemistry
timeFrame: At each visit outlined for 3 months
measure: Physical activity
timeFrame: At each visit outlined for 3 months
measure: Physical activity
timeFrame: At each visit outlined for 3 months
measure: Physical activity
timeFrame: At each visit outlined for 3 months
measure: Quality of life: General
timeFrame: At each visit outlined for 3 months
measure: Quality of life: Appetite
timeFrame: At each visit outlined for 3 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Department of Medicine Center for Human Nutrition
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Zhaoping Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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