Nutrition Support to Improve Outcomes in Patients With Unresectable Pancreatic Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 8/16/2018 |
| Start Date: | July 19, 2016 |
| End Date: | July 19, 2020 |
| Contact: | Gail D Thames, B.A |
| Email: | gthames@mednet.ucla.edu |
| Phone: | 310-825-0453 |
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.
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.
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.
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.
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
We found this trial at
1
site
Los Angeles, California 90095
Principal Investigator: Zhaoping Li, MD, PhD
Phone: 310-825-0453
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