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

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ClinicalTrials.gov Identifier: NCT02745197
Recruitment Status : Withdrawn (change in concept)
First Posted : April 20, 2016
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Dietary Supplement: Nutritional Supplement Dietary Supplement: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Factors That Regulate Components of a Nutritional Supplement to Support Skeletal Muscle in Cancer Patients
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nutritional Supplement
2 nutritional supplement capsules, taken by mouth 3 times per day, for approximately 10 to 15 weeks.
Dietary Supplement: Nutritional Supplement
Participants will take 2 capsules, containing the nutritional supplement, 3 times per day.

Placebo Comparator: Placebo
2 placebo capsules, taken by mouth 3 times per day, for approximately 10 to 15 weeks.
Dietary Supplement: Placebo
Participants will take 2 capsules, containing a placebo, 3 times per day.




Primary Outcome Measures :
  1. Muscle fatty acid content [ Time Frame: At time of tumor removal surgery ]
    Quantification of muscle triglyceride fatty acid (ug/g)


Secondary Outcome Measures :
  1. Plasma levels of the nutritional supplement [ Time Frame: Baseline (before initiation of capsule consumption), day of tumor removal surgery (an average of 2-5 weeks from baseline), and day of post-surgery follow-up CT scan (an average of 8-10 weeks after surgery) ]
    Quantification of the plasma concentration of nutritional supplement components (ug/mL)

  2. Determine computed tomography (CT)-derived body composition [ Time Frame: Within 45 days before tumor removal surgery, and day of post-surgery follow-up CT scan (an average of 8-10 weeks after surgery) ]
    Quantitatively determine body composition as assessed by computed tomography (CT) scans, relative to stature (cm2/m2)

  3. Plasma C-reactive protein [ Time Frame: Baseline (before initiation of capsule consumption), day of tumor removal surgery (an average of 2-5 weeks from baseline), and day of post-surgery follow-up CT scan (an average of 8-10 weeks after surgery) ]
    Plasma quantification of C-reactive protein (mg/dL)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02745197


Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Vera Mazurak, Ph.D. University of Alberta

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02745197     History of Changes
Other Study ID Numbers: HREBA-CC-15-0218
First Posted: April 20, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases