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 : Not yet recruiting
First Posted : April 20, 2016
Last Update Posted : December 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Dietary Supplement: Nutritional Supplement Dietary Supplement: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|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 :||January 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||January 2021|
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.
- Muscle fatty acid content [ Time Frame: At time of tumor removal surgery ]Quantification of muscle triglyceride fatty acid (ug/g)
- 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)
- 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)
- 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)
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
|Contact: Vera Mazurak, Ph.D.||email@example.com|
|Contact: Oliver Bathe, MD|
|Principal Investigator:||Vera Mazurak, Ph.D.||University of Alberta|