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2016-07-19
2021-10-01
2021-10-01
2
NCT02681601
Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center
INTERVENTIONAL
Nutrition Support to Improve Outcomes in Patients With Unresectable Pancreatic Cancer
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-01-27 | N/A | 2022-08-01 |
2016-02-11 | N/A | 2022-08-03 |
2016-02-12 | N/A | 2021-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Diet + Nutrawell Powder with Fish Oil 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
DIETARY_SUPPLEMENT: OmegaRich fish oil supplement
|
| ACTIVE_COMPARATOR: Dietary Intervention Only 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
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
MALE
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
