Summary

Eligibility
for males ages 18-75 (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Zhaoping Li, MD, PhD (ucla)

Description

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.

Details

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.

Keywords

Cancer of Pancreas Diet, Food, and Nutrition Pancreatic Neoplasms Nutrawell Powder Diet Only OmegaRich fish oil supplement

Eligibility

You can join if…

Open to males ages 18-75

  • 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

You CAN'T join if...

  • 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

Location

  • UCLA Department of Medicine Center for Human Nutrition accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at UC Cancer

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jonsson Comprehensive Cancer Center
ID
NCT02681601
Study Type
Interventional
Last Updated