Adenocarcinoma of the PancreasPhase 4EPCNCT01401387
Pancreatic Enzyme Suppletion in Pancreatic Cancer
A Phase 4 study testing Timing of start treatment with pancreatic enzymes in people with Adenocarcinoma of the Pancreas and Normal Pancreatic Exocrine Function, run by Foundation for Liver Research at 1 site in Netherlands.
Trial summary
This study will evaluate the effect of immediate pancreatic enzyme suppletion on the physical and mental health status and survival of patients who are diagnosed with pancreatic cancer and are highly likely to develop exocrine pancreatic insufficiency during their disease process. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Pancreas, Normal Pancreatic Exocrine Function
- What is being tested?
- Timing of start treatment with pancreatic enzymes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2011to May 2013
- Phase
- Phase 4
- 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
- Adenocarcinoma of the pancreas (histologically confirmed)
- Normal exocrine pancreatic function (Fecal Elastase test > 0.2 mg/g)
- Capable and willing to follow instructions given by the physician.
Who cannot join
- Other causes of fat malabsorption (celiac disease, IBD, and major gastrointestinal surgery).
- < 18 years.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Erasmus Medical Center
Rotterdam, South Holland, 3000 WB
About this study
Official title: Exocrine Pancreatic Insufficiency in Pancreatic Cancer: Evaluating the Need and Efficacy of Pancreatic Enzyme Replacement Therapy
This study will evaluate the effect of immediate pancreatic enzyme suppletion on the physical and mental health status and survival of patients who are diagnosed with pancreatic cancer and are highly likely to develop exocrine pancreatic insufficiency during their disease process.
Read the detailed description
Weight loss in cancer is caused by primary tumour effects and secondary effects (e.g. side effects of treatment, mechanical and intestinal obstruction). In pancreatic cancer, additional weight loss and malnutrition may be due to the development of exocrine pancreatic insufficiency (EPI). The presence of EPI in pancreatic cancer is frequently overlooked, because the focus of treatment is directed at possible surgery or chemotherapy and its potential side effects. Although studies have proven that pancreatic enzymes may prevent or decrease weight loss, they are seldom being prescribed.
- Being tested
- Timing of start treatment with pancreatic enzymes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing of start treatment with pancreatic enzymesOther
Also called Panzytrat 'HL'
Patients who are randomised to standard treatment will start taking pancreatic enzymes only if they develop steatorrhea-related symptoms in combination with at least a 10% decrease in body weight (index weight at the time of randomisation).
Timing of start treatment with pancreatic enzymesOther
Also called Panzytrat 'HL'
Patients who are allocated to the anticipative group will start enzyme suppletion immediately and receive dietary consultation after randomization, regardless of symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | Active comparator | Treatment with pancreatic enzymes after clinical sings and symptoms of steatorrhea and 10% decrease of weight at time of randomisation. Receives: Other: Timing of start treatment with pancreatic enzymes |
| Preventive treatment | Active comparator | Patients will be prescribed with pancreatic enzymes immediately after diagnosis with pancreatic cancer, regardless of the presence of steatorrhea Receives: Other: Timing of start treatment with pancreatic enzymes |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate if prescribing pancreatic enzymes in patients with pancreatic cancer leads to a decrease in weight loss.
Percentage of change in body weight ((index weight - monthly weight)/ index weight) x100% during the 6 months of follow-up. This will be measured on a monthly basis and measured by area under the ROC (Receiver Operating Characteristic) curve
Measured: every month during 6 months after inclusion
Secondary outcomes (3)
improvement of the nutritional status
Nutritional deficiencies, 1 sample of blood will be drawn (3 times 8ml of blood):
- Glucose, HbA1c (glycol Hb)
- Magnesium, phosphate, ferritin
- Hb
- albumin
- total protein
- calcium
- folic acid
- vitamin A, E, B12
- 1,25-di-OH-Vitamine D
- 25-hydroxy vitamin D (25-OH-vitamin D)
Measured: every three months
quality-of-life
SF36 questionnaire
Measured: on a monthly base during 6 months after inclusion
improvement of the nutritional status
A monthly patient journal which will focus on the presence or absence of steatorrhea-related symptoms
Measured: every month during six months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
Why it stopped: study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the PancreasStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Liver Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Bruno, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401387
- Sponsor's protocol ID
- EPC 11-01
- Other IDs
- 2011-003373-28
- Acronym
- EPC
- Status last verified
- Feb 2013
- First submitted
- 21 Jul 2011
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exocrine Pancreatic Insufficiency in Pancreatic Cancer: Evaluating the Need and Efficacy of Pancreatic Enzyme Replacement Therapy
- ClinicalTrials.gov ID
- NCT01401387
- Acronym / sponsor ID
- EPC / EPC 11-01
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Foundation for Liver ResearchUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 25 Jul 2011 (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 will evaluate the effect of immediate pancreatic enzyme suppletion on the physical and mental health status and survival of patients who are diagnosed with pancreatic cancer and are highly likely to develop exocrine pancreatic insufficiency during their disease process.
Detailed description
Weight loss in cancer is caused by primary tumour effects and secondary effects (e.g. side effects of treatment, mechanical and intestinal obstruction). In pancreatic cancer, additional weight loss and malnutrition may be due to the development of exocrine pancreatic insufficiency (EPI). The presence of EPI in pancreatic cancer is frequently overlooked, because the focus of treatment is directed at possible surgery or chemotherapy and its potential side effects. Although studies have proven that pancreatic enzymes may prevent or decrease weight loss, they are seldom being prescribed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | Active comparator | Other: Timing of start treatment with pancreatic enzymesTreatment with pancreatic enzymes after clinical sings and symptoms of steatorrhea and 10% decrease of weight at time of randomisation. |
| Preventive treatment | Active comparator | Other: Timing of start treatment with pancreatic enzymesPatients will be prescribed with pancreatic enzymes immediately after diagnosis with pancreatic cancer, regardless of the presence of steatorrhea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adenocarcinoma of the pancreas (histologically confirmed)
- Normal exocrine pancreatic function (Fecal Elastase test > 0.2 mg/g)
- Capable and willing to follow instructions given by the physician.
Key exclusion criteria (2 listed)
- Other causes of fat malabsorption (celiac disease, IBD, and major gastrointestinal surgery).
- < 18 years.
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 |
|---|---|---|
| Timing of start treatment with pancreatic enzymesAlso: Panzytrat 'HL'Patients who are randomised to standard treatment will start taking pancreatic enzymes only if they develop steatorrhea-related symptoms in combination with at least a 10% decrease in body weight (index weight at the time of randomisation). | Other | Standard treatment |
| Timing of start treatment with pancreatic enzymesAlso: Panzytrat 'HL'Patients who are allocated to the anticipative group will start enzyme suppletion immediately and receive dietary consultation after randomization, regardless of symptoms. | Other | Preventive treatment |
Primary outcome
To evaluate if prescribing pancreatic enzymes in patients with pancreatic cancer leads to a decrease in weight loss.
Time frame: every month during 6 months after inclusion
Percentage of change in body weight ((index weight - monthly weight)/ index weight) x100% during the 6 months of follow-up. This will be measured on a monthly basis and measured by area under the ROC (Receiver Operating Characteristic) curve
3 secondary outcomes
improvement of the nutritional status
Time frame: every three months
quality-of-life
Time frame: on a monthly base during 6 months after inclusion
improvement of the nutritional status
Time frame: every month during six months after inclusion
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 22 Feb 2013.
- Bruno MJ, Haverkort EB, Tijssen GP, Tytgat GN, van Leeuwen DJ. Placebo controlled trial of enteric coated pancreatin microsphere treatment in patients with unresectable cancer of the pancreatic head region. Gut. 1998 Jan;42(1):92-6.Link provided by the sponsor.
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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.
Marco Bruno, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Timing of start treatment with pancreatic enzymes in people with Adenocarcinoma of the Pancreas and Normal Pancreatic Exocrine Function, run by Foundation for Liver Research at 1 site in Netherlands.
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 3 inclusion and 2 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 22 Feb 2013. 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 Netherlands. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To evaluate if prescribing pancreatic enzymes in patients with pancreatic cancer leads to a decrease in weight loss. (time frame: every month during 6 months after inclusion). 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 22 Feb 2013.