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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01401387
Other study ID # EPC 11-01
Secondary ID 2011-003373-28
Status Withdrawn
Phase Phase 4
First received July 21, 2011
Last updated February 21, 2013
Start date October 2011
Est. completion date May 2013

Study information

Verified date February 2013
Source Foundation for Liver Research
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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).
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.

Locations

Country Name City State
Netherlands Erasmus Medical Center Rotterdam Zuid-Holland

Sponsors (1)

Lead Sponsor Collaborator
Foundation for Liver Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary quality-of-life SF36 questionnaire on a monthly base during 6 months after inclusion No
Secondary 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 No
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