Pancreatic Enzyme Suppletion in Pancreatic Cancer (EPC)
This study has been withdrawn prior to enrollment.
(study never started)
Sponsor:
Foundation for Liver Research
Information provided by (Responsible Party):
Foundation for Liver Research
ClinicalTrials.gov Identifier:
NCT01401387
First received: July 21, 2011
Last updated: February 21, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Adenocarcinoma of the Pancreas Normal Pancreatic Exocrine Function |
Other: Timing of start treatment with pancreatic enzymes |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Exocrine Pancreatic Insufficiency in Pancreatic Cancer: Evaluating the Need and Efficacy of Pancreatic Enzyme Replacement Therapy |
Resource links provided by NLM:
Further study details as provided by Foundation for Liver Research:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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
Secondary Outcome Measures:
- improvement of the nutritional status [ Time Frame: every three months ] [ Designated as safety issue: No ]
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)
- quality-of-life [ Time Frame: on a monthly base during 6 months after inclusion ] [ Designated as safety issue: No ]SF36 questionnaire
- improvement of the nutritional status [ Time Frame: every month during six months after inclusion ] [ Designated as safety issue: No ]A monthly patient journal which will focus on the presence or absence of steatorrhea-related symptoms
| Enrollment: | 0 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
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 Name: Panzytrat 'HL'
|
|
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
Patients who are allocated to the anticipative group will start enzyme suppletion immediately and receive dietary consultation after randomization, regardless of symptoms.
Other Name: Panzytrat 'HL'
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Other causes of fat malabsorption (celiac disease, IBD, and major gastrointestinal surgery).
- < 18 years.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401387
Locations
| Netherlands | |
| Erasmus Medical Center | |
| Rotterdam, Zuid-Holland, Netherlands, 3000 WB | |
Sponsors and Collaborators
Foundation for Liver Research
Investigators
| Principal Investigator: | Marco Bruno, MD, PhD | Erasmus Medical Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Foundation for Liver Research |
| ClinicalTrials.gov Identifier: | NCT01401387 History of Changes |
| Other Study ID Numbers: | EPC 11-01, 2011-003373-28 |
| Study First Received: | July 21, 2011 |
| Last Updated: | February 21, 2013 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Exocrine Pancreatic Insufficiency Pancreatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Pancreatic Diseases |
Digestive System Diseases Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Endocrine System Diseases Pancreatin Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013