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2011-10
2013-05
2013-05
0
NCT01401387
Foundation for Liver Research
Foundation for Liver Research
INTERVENTIONAL
Pancreatic Enzyme Suppletion in Pancreatic Cancer
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2011-07-21 | N/A | 2013-02-21 |
2011-07-22 | N/A | 2013-02-22 |
2011-07-25 | N/A | 2013-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Standard treatment Treatment with pancreatic enzymes after clinical sings and symptoms of steatorrhea and 10% decrease of weight at time of randomisation. | OTHER: Timing of start treatment with pancreatic enzymes
|
| ACTIVE_COMPARATOR: Preventive treatment Patients will be prescribed with pancreatic enzymes immediately after diagnosis with pancreatic cancer, regardless of the presence of steatorrhea | OTHER: Timing of start treatment with pancreatic enzymes
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | every month during 6 months after inclusion |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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) | every three months |
| quality-of-life | SF36 questionnaire | 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 | every month during six months after inclusion |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
