Treatment of Pancreatic Insufficiency Using Creon in Patients with Pancreatic Cancer

Phase 2

• Conditions: Pancreatic carcinoma; Cancer - Pancreatic; Cancer - Biliary tree (gall bladder and bile duct)

• Registration Number: ACTRN12612000299808
• Lead Sponsor: Calvary Mater Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Metastatic or locally advanced pancreatic cancer
Histologically proven adenocarcinoma; or elevated Ca 19-9 with evidence of a pancreatic mass
ECOG 0-2
Able to participate in the assessement schedule
Being treated with palliative intent

Exclusion Criteria

Already on pancreatic enzyme replacement for any reason
Presence of steatorrhoea
Expected survival of less than 2 months
Patients who have had resection or radiotherapy with curative intent with no evidence of recurrent disease
Hypersensitivity or intolerance to any of the study medications

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in weight. The hypothesis is that enzyme supplementation will stop weight loss or cause body weight to increase. Weight will be measured on the same scales at each clinic visit, every month for the first 3 visits, then 3 monthly.[Baseline, then monthly for 2 months, then every 3 months until participant concludes trial participation.]

Secondary Outcome Measures

Name	Time	Method
Quality of life, using the EORTC QLQ C30 instrument, and the PAN-26 pancreatic module.[Baseline, then monthly for 2 months, then every 3 months until participant concludes trial participation.];Survival. All patients will be followed until death. This data is captured using hospital electronic records and through regular contact with participants and their families.[12 months];Nutrition, assessed by a dietitian, who will performa standardised assessment using the patient generated subjective global assessment (PGSGA), a validated tool for assessing nutritionin cancer patients. It involves a questionnaire, skin fold measurements and dietary history to form a composite score.[Baseline, then monthly for 2 months, then every 3 months until participant concludes trial participation.]