Pancreatic Enzyme Supplementation in Patients With Unresectable Pancreatic Cancer (PESUP)

Pancreatic Cancer Clinical Trial

Official title:

Phase 2 Study of Randomized Controlled Trial of Pancreatic Enzyme Supplementation in Patients With Unresectable Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01587534
• Other study ID #: NCCCTS-11-570
• Status: Completed
• Phase: Phase 2
• First received: April 25, 2012
• Last updated: April 13, 2015
• Start date: October 2011
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• To be eligible for inclusion, each patient must fulfill each of the following criteria:

1. Subjects with unresectable pancreatic cancer preferably proven by cytology or histology

2. not eligible for surgery because of poor general condition, local unresectability, or advanced disease with metastases

3. Age over 18 years old

4. Performance status (ECOG scale): 0-2

5. Agree to record daily food intake

6. Patients should sign a written informed consent before study entry

Exclusion Criteria:

• Patients will be excluded from the study for any of the following reasons:

1. History of major gastrointestinal surgery

2. history of chronic gastrointestinal disease (for example, Crohn's disease)

3. Diabetes decompensated

4. Diabetes mellitus with severe gastroparesis

5. presence of pancreatic pseudocysts impeding gastric or duodenal passage

6. any use of antacids, mucosal protective agents, H 2 receptor antagonists, or proton pump inhibitors that could not be discontinued

7. concomitant medication affecting gastroduodenal motility (e.g. metoclopramide and erythromycin), or interfering with bile secretion (e.g. bile acids)

8. Abusive use of alcohol in the three months preceding the study;

9. known allergy to pancreatin

10. Any major surgery within 4 weeks prior to study treatment

11. Pregnant or lactating woman

12. Any patients judged by the investigator to be unfit to participate in the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Norzyme
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.

Locations

Country	Name	City	State
Korea, Republic of	NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu,	Goyang-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Center, Korea	Pharmbio Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change in body weight at eight weeks after the randomisation	the percentage change in body weight at eight weeks after the randomisation	at baseline and 4, 8 week, 24 week	No
Secondary	Frequency and intensity of abdominal pain daily		at baseline and 4, 8 week, 24 week	No
Secondary	Frequency of bowel movements per day		at baseline and 4, 8 week, 24 week	No