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alpha-Tocopherol

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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.

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.

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.

Nutrawell Powder

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

Diet Only

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.

OmegaRich fish oil supplement

Zhaoping Li, MD, PhD

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.

Nutrition Support to Improve Outcomes in Patients With Unresectable Pancreatic Cancer

Body Composition: kilogram weight of lean body mass

All subjects will be provided a pedometer to record daily steps.

A 6 minute walk will be done at each visit.

Measured with short form health survey (SF36)

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)

Do Well Laboratories Inc.

Hirshberg Foundation for Pancreatic Cancer Research

Jonsson Comprehensive Cancer Center

Gastrointestinal Agents

Pancrelipase

Pancreatin

Diet counseling will be delivered using visual communication (e.g., Skype). Participants will be provided a computer tablet for the intervention with participants randomized to receive diet counseling.

Diet and exercise counseling will be delivered using visual communication (e.g., Skype). Participants will be provided a computer tablet for the intervention with participants randomized to receive diet and exercise counseling also receiving a fitness bracelet to facilitate counseling by the certified Cancer Exercise Trainer.

Diet and exercise counseling will be delivered using visual communication (e.g., Skype). Participants will be provided a computer tablet for the intervention with participants randomized to receive diet and exercise counseling.

Diet + Exercise

Determine feasibility of a randomized controlled trial (RCT) in pancreatic (\& other foregut) cancer patients comparing the effects of diet alone vs. diet+exercise on functional and clinical outcomes.

Foregut cancers such as pancreatic cancer cause significant side effects and poorer health-related quality of life (QOL), as well as a 5-year survival rate of only 6%. Importantly, the reduction in physical functioning caused by this cancer and its therapies is associated with higher mortality risk. Although multiple studies in more prevalent cancer types support exercise benefits (e.g., improved physical functioning), data cannot be generalized from one cancer type to another. Little is known about exercise feasibility and benefits in pancreatic (\& other foregut) cancer patients, and no data regarding potential mechanistic outcomes that may explain the link between poor physical performance status and cancer survival have been reported. We will enroll 20 patients with pancreatic adenocarcinoma (or other foregut cancer) who are expected to undergo surgical resection or who are within 3 years of surgical resection, in a pilot project involving a 6-month home-based lifestyle intervention (diet along versus diet+exercise). Research assessments will be done pre-surgery (if applicable), post-surgery (and prior to starting the intervention), 3 months, and 6 months post-surgery. Intervention counseling will be delivered using visual communication (e.g., Skype). Participants will be provided a computer tablet for the intervention with participants randomized to receive exercise counseling also receiving a fitness bracelet to facilitate counseling by the certified Cancer Exercise Trainer. Our primary study aim is to determine feasibility of a randomized controlled trial (RCT) in pancreatic cancer patients comparing the effects of diet alone with diet+exercise on pancreatic cancer-related functional and disease outcomes; feasibility measures include recruitment, retention, intervention adherence, assessment completion, adverse events, and participant satisfaction. Our secondary study aim is to determine the effect of diet+exercise compared with diet alone on physical functioning and QOL. Also, we will draw and store blood samples so that additional funds can be requested to test intervention effects on biomarkers of cancer risk (e.g., tumor immunity, inflammatory cytokines, etc.). The goal of the study is to advance the exercise oncology field into an understudied cancer type and develop an intervention that will improve the survivorship care of pancreatic cancer patients through distance-delivered counseling methods.

Diet and Exercise After Pancreatic Cancer

Diet and Exercise After Pancreatic Cancer: Clinical and Functional Outcomes (Non Canonical WNT Signaling in Colorectal Cancer)

Number of participants excluded or not agreeing to participate

Feasibility measure (e.g. percent of assessments completed, percent of counseling sessions completed, etc.)

Number of participants who dropout or are withdrawn

Exploratory data related to within and between group (diet and diet+exercise) differences

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nutrition Support to Improve Outcomes in Patients With Unresectable Pancreatic Cancer	NCT02681601	Cancer of Pancr...	Nutrawell Powde... Diet Only OmegaRich fish ...	18 Years - 75 Years	Jonsson Comprehensive Cancer Center
Nutrition Support to Improve Outcomes in Patients With Unresectable Pancreatic Cancer	NCT02681601	Cancer of Pancr...	Nutrawell Powde... Diet Only OmegaRich fish ...	18 Years - 75 Years	Jonsson Comprehensive Cancer Center
Diet and Exercise After Pancreatic Cancer	NCT03187028	Pancreatic Canc...	Diet Only Diet + Exercise	18 Years -	University of Alabama at Birmingham

Spots Global Cancer Trial Database for diet only

Every month we try and update this database with for diet only cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for diet only

Every month we try and update this database with for diet only cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for diet only cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.