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Nutrition Support to Improve Outcomes in Patients With Unresectable Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02681601
Recruitment Status : Recruiting
First Posted : February 12, 2016
Last Update Posted : August 5, 2020
Sponsor:
Collaborators:
Do Well Laboratories Inc.
Hirshberg Foundation for Pancreatic Cancer Research
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Cancer of Pancreas Dietary Supplement: Nutrawell Powder Other: Diet Only Dietary Supplement: OmegaRich fish oil supplement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nutrition Support to Improve Outcomes in Patients With Unresectable Pancreatic Cancer
Actual Study Start Date : July 19, 2016
Estimated Primary Completion Date : July 19, 2021
Estimated Study Completion Date : July 19, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil

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

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.


Dietary Supplement: OmegaRich 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.


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
Subjects will be evaluated by a registered dietitian and randomized to diet prescription (55% carbohydrate, 30% fat and 15% protein)




Primary Outcome Measures :
  1. Anthropometric measurement: Weight [ Time Frame: At each visit outlined for 3 months ]
    Weight in Kilograms

  2. Anthropometric measurement: Body Composition [ Time Frame: At each visit outlined for 3 months ]
    Body Composition: kilogram weight of lean body mass


Secondary Outcome Measures :
  1. Blood biochemistry [ Time Frame: At each visit outlined for 3 months ]
    complete blood count

  2. Blood biochemistry [ Time Frame: At each visit outlined for 3 months ]
    Blood electrolytes

  3. Blood biochemistry [ Time Frame: At each visit outlined for 3 months ]
    Liver function test

  4. Blood biochemistry [ Time Frame: At each visit outlined for 3 months ]
    Lipid panel

  5. Blood biochemistry [ Time Frame: At each visit outlined for 3 months ]
    Pancreatic tumor markers

  6. Blood biochemistry [ Time Frame: At each visit outlined for 3 months ]
    Inflammatory markers

  7. Physical activity [ Time Frame: At each visit outlined for 3 months ]
    All subjects will be provided a pedometer to record daily steps.

  8. Physical activity [ Time Frame: At each visit outlined for 3 months ]
    A 6 minute walk will be done at each visit.

  9. Physical activity [ Time Frame: At each visit outlined for 3 months ]
    Karnofsky performance score

  10. Quality of life: General [ Time Frame: At each visit outlined for 3 months ]
    Measured with short form health survey (SF36)

  11. Quality of life: Appetite [ Time Frame: 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02681601


Contacts
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Contact: Gail D Thames, B.A 310-825-0453 gthames@mednet.ucla.edu
Contact: Alicia Yang, RD 310-206-8292 adyang@mednet.ucla.edu

Locations
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United States, California
UCLA Department of Medicine Center for Human Nutrition Recruiting
Los Angeles, California, United States, 90095
Contact: Gail D Thames, BA    310-825-0453    gthames@mednet.ucla.edu   
Contact: Alicia F Yang, RD    310.206.2582    ayang@mednet.ucla.edu   
Principal Investigator: Zhaoping Li, MD, PhD         
Sub-Investigator: Vijaya Surampudi, MD, MS         
Principal Investigator: Susanne Henning, PhD, RD         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Do Well Laboratories Inc.
Hirshberg Foundation for Pancreatic Cancer Research
Investigators
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Principal Investigator: Zhaoping Li, MD, PhD University of California, Los Angeles
Publications:

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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02681601    
Other Study ID Numbers: 15-001926
First Posted: February 12, 2016    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jonsson Comprehensive Cancer Center:
Diet, Food, and Nutrition
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases