Pancreatic CancerPhase 2NCT02745197
A Study to See Whether a Nutritional Supplement is Beneficial for Patients With Pancreatic Cancer
A Phase 2 study testing Nutritional Supplement in people with Pancreatic Cancer, run by University of Alberta.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Nutritional Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2017to Oct 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: Factors That Regulate Components of a Nutritional Supplement to Support Skeletal Muscle in Cancer Patients
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.
- Conditions
- Pancreatic Cancer
- Being tested
- Nutritional Supplement, Placebo
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional SupplementDietary supplement
Participants will take 2 capsules, containing the nutritional supplement, 3 times per day.
PlaceboDietary supplement
Participants will take 2 capsules, containing a placebo, 3 times per day.
| Study group | Role | What they receive |
|---|---|---|
| Nutritional Supplement | Experimental | 2 nutritional supplement capsules, taken by mouth 3 times per day, for approximately 10 to 15 weeks. Receives: Dietary Supplement: Nutritional Supplement |
| Placebo | Placebo comparator | 2 placebo capsules, taken by mouth 3 times per day, for approximately 10 to 15 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle fatty acid content
Quantification of muscle triglyceride fatty acid (ug/g)
Measured: At time of tumor removal surgery
Secondary outcomes (3)
Plasma levels of the nutritional supplement
Quantification of the plasma concentration of nutritional supplement components (ug/mL)
Measured: 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)
Determine computed tomography (CT)-derived body composition
Quantitatively determine body composition as assessed by computed tomography (CT) scans, relative to stature (cm2/m2)
Measured: Within 45 days before tumor removal surgery, and day of post-surgery follow-up CT scan (an average of 8-10 weeks after surgery)
Plasma C-reactive protein
Plasma quantification of C-reactive protein (mg/dL)
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startMay 2017 (estimated)
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Why it stopped: change in concept
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vera Mazurak, Ph.D., Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745197
- Sponsor's protocol ID
- HREBA-CC-15-0218
- Status last verified
- Oct 2018
- First submitted
- 13 Jan 2016
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors That Regulate Components of a Nutritional Supplement to Support Skeletal Muscle in Cancer Patients
- ClinicalTrials.gov ID
- NCT02745197
- Acronym / sponsor ID
- HREBA-CC-15-0218
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: change in concept
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- May 2017 (estimated)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional Supplement | Experimental | Dietary Supplement: Nutritional Supplement2 nutritional supplement capsules, taken by mouth 3 times per day, for approximately 10 to 15 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo2 placebo capsules, taken by mouth 3 times per day, for approximately 10 to 15 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional SupplementParticipants will take 2 capsules, containing the nutritional supplement, 3 times per day. | Dietary supplement | Nutritional Supplement |
| PlaceboParticipants will take 2 capsules, containing a placebo, 3 times per day. | Dietary supplement | Placebo |
Primary outcome
Muscle fatty acid content
Time frame: At time of tumor removal surgery
Quantification of muscle triglyceride fatty acid (ug/g)
3 secondary outcomes
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)
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)
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vera Mazurak, Ph.D. principal investigator
University of Alberta
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nutritional Supplement in people with Pancreatic Cancer, run by University of Alberta.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle fatty acid content (time frame: At time of tumor removal surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.