Pancreatic CancerPhase 2NCT01587534
Pancreatic Enzyme Supplementation in Patients With Unresectable Pancreatic Cancer (PESUP)
A Phase 2 study testing Norzyme in people with Pancreatic Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
The investigators planned a prospective, randomized, placebo controlled trial to test the hypothesis that weight loss in patients with unresectable pancreatic cancer with occlusion of the pancreatic duct can be reduced or prevented by pancreatic enzyme replacement therapy in combination with dietary counseling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Norzyme
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2011to Dec 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for inclusion, each patient must fulfill each of the following criteria:
- Subjects with unresectable pancreatic cancer preferably proven by cytology or histology
- not eligible for surgery because of poor general condition, local unresectability, or advanced disease with metastases
- Age over 18 years old
- Performance status (ECOG scale): 0-2
- Agree to record daily food intake
- Patients should sign a written informed consent before study entry
Who cannot join
- Patients will be excluded from the study for any of the following reasons:
- History of major gastrointestinal surgery
- history of chronic gastrointestinal disease (for example, Crohn's disease)
- Diabetes decompensated
- Diabetes mellitus with severe gastroparesis
- presence of pancreatic pseudocysts impeding gastric or duodenal passage
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- any use of antacids, mucosal protective agents, H 2 receptor antagonists, or proton pump inhibitors that could not be discontinued
- concomitant medication affecting gastroduodenal motility (e.g. metoclopramide and erythromycin), or interfering with bile secretion (e.g. bile acids)
- Abusive use of alcohol in the three months preceding the study;
- known allergy to pancreatin
- Any major surgery within 4 weeks prior to study treatment
- Pregnant or lactating woman
- Any patients judged by the investigator to be unfit to participate in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu,
Goyang-si, Gyeonggi-do, 410-769
About this study
Official title: Phase 2 Study of Randomized Controlled Trial of Pancreatic Enzyme Supplementation in Patients With Unresectable Pancreatic Cancer
The investigators planned a prospective, randomized, placebo controlled trial to test the hypothesis that weight loss in patients with unresectable pancreatic cancer with occlusion of the pancreatic duct can be reduced or prevented by pancreatic enzyme replacement therapy in combination with dietary counseling.
Read the detailed description
Pancreatic cancer has the worst overall prognosis with fewer than 3% of affected patients alive five years after the initial diagnosis. It is the fourth leading cause of death from cancer in Korea. 80-90% of patients have locally unresectable or advanced metastatic disease and for these patients only palliative treatment options remain. Symptoms include obstructive jaundice, duodenal obstruction, pain, and weight loss. Palliative treatment is mainly directed against the former three. Interventions to prevent (further) weight loss have as yet received little or no attention, in spite of the frequent occurrence of this symptom. About 90% of patients with pancreatic carcinoma have weight loss at the time of diagnosis. In addition, Weight loss prior to chemotherapy was found to have a prognostic effect on survival in a range of different tumor types.
There is a limited range of studies investigating the incidence of exocrine insufficiency in pancreatic cancer. Studies available indicate a high incidence of exocrine insufficiency in unresectable pancreatic cancer patients and patients before and after pancreatic cancer surgery. The previous reports showed that 68-92% of pancreatic cancer patients were exocrine insufficient. Such high incidences of exocrine insufficiency in pancreatic cancer patients support the use of pancreatic enzyme replacement therapy in this patient group. The guidelines for the management of patients with pancreatic cancer periampullary and ampullary carcinoma published in Gut promote the use of pancreatic enzyme replacement therapy to maintain weight and to increase quality of life in this patient group. However, studies evaluating the efficacy of pancreatic enzyme replacement therapy in pancreatic cancer are lacking to date. There have been no systematic reviews and only one randomized control trial involving a small sample of 21 patients with unresectable cancer of the pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Being tested
- Norzyme
- Keywords
- Unresectable Pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorzymeDrug
Also called placebo
Patients will be randomized to receive either pancreatic enzyme replacement therapy or placebo. Patients will use two capsules three times daily during main meals and one capsule three times daily during in between snacks. The pancreatic enzyme preparation under investigation is Norzyme ® 6 - 9 tablets per day.
| Study group | Role | What they receive |
|---|---|---|
| pancreatic enzyme replacement therapy | Experimental | The pancreatic enzyme preparation under investigation is Norzyme ® 6 - 9 tablets per day. Receives: Drug: Norzyme |
| Placebo | No intervention | The placebo will match the active drug in appearance, taste, and weight and contained pharmacologically inactive substances. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in body weight at eight weeks after the randomisation
the percentage change in body weight at eight weeks after the randomisation
Measured: at baseline and 4, 8 week, 24 week
Secondary outcomes (2)
Frequency and intensity of abdominal pain daily
Measured: at baseline and 4, 8 week, 24 week
Frequency of bowel movements per day
Measured: at baseline and 4, 8 week, 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startOct 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Pharmbio Korea Co., Ltd.
- Responsible party
- Principal investigator, Sang Myung Woo, National Cancer Center, Korea
- Investigators
- Sangmyung Woo, M.D, Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587534
- Sponsor's protocol ID
- NCCCTS-11-570
- Status last verified
- Apr 2015
- First submitted
- 25 Apr 2012
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Woo SM, Joo J, Kim SY, Park SJ, Han SS, Kim TH, Koh YH, Chung SH, Kim YH, Moon H, Hong EK, Lee WJ. Efficacy of pancreatic exocrine replacement therapy for patients with unresectable pancreatic cancer in a randomized trial. Pancreatology. 2016 Nov-Dec;16(6):1099-1105. doi: 10.1016/j.pan.2016.09.001. Epub 2016 Sep 4.
PubMed 27618657
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Randomized Controlled Trial of Pancreatic Enzyme Supplementation in Patients With Unresectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01587534
- Acronym / sponsor ID
- NCCCTS-11-570
- Conditions
- Pancreatic Cancer
- Keywords
- Unresectable Pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Pharmbio Korea Co., Ltd.
- Study start
- Oct 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Apr 2012 (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.
The investigators planned a prospective, randomized, placebo controlled trial to test the hypothesis that weight loss in patients with unresectable pancreatic cancer with occlusion of the pancreatic duct can be reduced or prevented by pancreatic enzyme replacement therapy in combination with dietary counseling.
Detailed description
Pancreatic cancer has the worst overall prognosis with fewer than 3% of affected patients alive five years after the initial diagnosis. It is the fourth leading cause of death from cancer in Korea. 80-90% of patients have locally unresectable or advanced metastatic disease and for these patients only palliative treatment options remain. Symptoms include obstructive jaundice, duodenal obstruction, pain, and weight loss. Palliative treatment is mainly directed against the former three. Interventions to prevent (further) weight loss have as yet received little or no attention, in spite of the frequent occurrence of this symptom. About 90% of patients with pancreatic carcinoma have weight loss at the time of diagnosis. In addition, Weight loss prior to chemotherapy was found to have a prognostic effect on survival in a range of different tumor types.
There is a limited range of studies investigating the incidence of exocrine insufficiency in pancreatic cancer. Studies available indicate a high incidence of exocrine insufficiency in unresectable pancreatic cancer patients and patients before and after pancreatic cancer surgery. The previous reports showed that 68-92% of pancreatic cancer patients were exocrine insufficient. Such high incidences of exocrine insufficiency in pancreatic cancer patients support the use of pancreatic enzyme replacement therapy in this patient group. The guidelines for the management of patients with pancreatic cancer periampullary and ampullary carcinoma published in Gut promote the use of pancreatic enzyme replacement therapy to maintain weight and to increase quality of life in this patient group. However, studies evaluating the efficacy of pancreatic enzyme replacement therapy in pancreatic cancer are lacking to date. There have been no systematic reviews and only one randomized control trial involving a small sample of 21 patients with unresectable cancer of the pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pancreatic enzyme replacement therapy | Experimental | Drug: NorzymeThe pancreatic enzyme preparation under investigation is Norzyme ® 6 - 9 tablets per day. |
| Placebo | No intervention | –The placebo will match the active drug in appearance, taste, and weight and contained pharmacologically inactive substances. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- To be eligible for inclusion, each patient must fulfill each of the following criteria:
Key exclusion criteria (13 listed)
- Patients will be excluded from the study for any of the following reasons:
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 |
|---|---|---|
| NorzymeAlso: placeboPatients will be randomized to receive either pancreatic enzyme replacement therapy or placebo. Patients will use two capsules three times daily during main meals and one capsule three times daily during in between snacks. The pancreatic enzyme preparation under investigation is Norzyme ® 6 - 9 tablets per day. | Drug | pancreatic enzyme replacement therapy |
Primary outcome
the change in body weight at eight weeks after the randomisation
Time frame: at baseline and 4, 8 week, 24 week
the percentage change in body weight at eight weeks after the randomisation
2 secondary outcomes
Frequency and intensity of abdominal pain daily
Time frame: at baseline and 4, 8 week, 24 week
Frequency of bowel movements per day
Time frame: at baseline and 4, 8 week, 24 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
- Derived from this study: PubMed 27618657Woo SM, Joo J, Kim SY, Park SJ, Han SS, Kim TH, Koh YH, Chung SH, Kim YH, Moon H, Hong EK, Lee WJ. Efficacy of pancreatic exocrine replacement therapy for patients with unresectable pancreatic cancer in a randomized trial. Pancreatology. 2016 Nov-Dec;16(6):1099-1105. doi: 10.1016/j.pan.2016.09.001. Epub 2016 Sep 4.
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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.
Sangmyung Woo, M.D principal investigator
National Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Norzyme in people with Pancreatic Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
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 7 inclusion and 13 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: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the change in body weight at eight weeks after the randomisation (time frame: at baseline and 4, 8 week, 24 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01587534, which also lists 1 linked publication.
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 15 Apr 2015.