A Study to See Whether a Nutritional Supplement is Beneficial for Patients With Pancreatic Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-31

Study Completion Date

2018-10-31

Brief Summary

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This study evaluates a nutritional supplement in the treatment of pancreatic cancer in adults. Half of the participants will receive the nutritional supplement, while the other half will receive a placebo.

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Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nutritional Supplement

2 nutritional supplement capsules, taken by mouth 3 times per day, for approximately 10 to 15 weeks.

Group Type EXPERIMENTAL

Nutritional Supplement

Intervention Type DIETARY_SUPPLEMENT

Participants will take 2 capsules, containing the nutritional supplement, 3 times per day.

Placebo

2 placebo capsules, taken by mouth 3 times per day, for approximately 10 to 15 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Participants will take 2 capsules, containing a placebo, 3 times per day.

Interventions

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Nutritional Supplement

Participants will take 2 capsules, containing the nutritional supplement, 3 times per day.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Participants will take 2 capsules, containing a placebo, 3 times per day.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patients with a newly diagnosed pancreatic tumor thought to be pancreatic cancer scheduled for resection of the tumor.
* Patients with a newly diagnosed pancreatic tumor thought to be pancreatic cancer, subsequently found to have biliary or ampullary cancer upon full pathological review, scheduled for resection of the tumor.
* Patients with a CT image, which includes scans of the 3rd lumbar region, taken within 45 days before tumor resection surgery.
* Ability to maintain oral intake.
* Ability to give written, informed consent.

Exclusion Criteria

* Patients found to have a diagnosis other than pancreatic, biliary, or ampullary cancer upon full pathological review.
* Patients with a benign tumor.
* Patients taking drugs that modify muscle metabolism.
* Patients with uncontrolled jaundice.
* A compliance rate of \<80%, excluding compliance during recovery from tumor resection surgery while in the hospital.
* Patients currently taking the nutritional supplement being investigated in this study.
* Patients in the placebo group who have plasma levels of the nutritional supplement components within the range of the nutritional supplement group at study time points when plasma levels of the nutritional supplement components are significantly higher in the nutritional supplement group versus the placebo group.
* Inadequate specimens.
* Known allergy to gelatin or glycerin.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No