None listed
Conditions
Brief summary
This study is a randomised controlled trial for patients with metastatic or locally advanced pancreatic cancer, comparing a drug named Creon - which acts as a pancreatic enzyme supplementation - to placebo, in order to determine its influence on change in weight. We will also look at the drug's effect on quality of life, nutrition and survival, with our expectation being that Creon will decrease the rate of weight loss, improve quality of life, nutrition and length of life. This study is being performed due to previous research showing a benefit to pancreatic enzyme supplements in patients with pancreatic cancer with a bile duct stent in place to relieve a blockage caused by the cancer. It is known that pancreatic cancer causes weight loss, and thought that poor absorption of nutrients may contribute to that weight loss. This study aims to assess whether aiding the aborption of nutrients leads to better nutrition, weight stabilisation, improved quality of life and improved survival. Trial details In this study you will be randomly assigned to either the active medication (the Creon drug made of pancreatic enzyme), or to an identical, but non-active placebo capsule. In either group, you will take 2 capsules of Creon/placebo with meals, and one capsule with snacks every day. After one month and depending on how you have tolerated the drug, the dosage may be increased to 3 capsules with meals and/or two capsules with snacks, depending on whether you are feeling bloated, flatulent and/or have diarrhoea. Overall, you will continue the treatment for at least 2 months. During the study will be assessed by study personnel including the doctor, nurse and dietitian. The assessments are weight measurement, questionnaires about nutrition, symptoms and quality of life. These visits will be monthly for 2 months, then every three months while you and other participants remain on the study. Who is it for? You may be eligible for this study if you have metastatic or locally advanced pancreatic cancer and aged 18 and over. Full details of whether or not you can participate can be found in the Inclusion Criteria section of this record.
Interventions
Oral pancreatic enzyme replacement therapy using a drug called Creon at a dose of 25,000 international units per capsule. This medication will be taken at an initial dose of 2 capsules with meals, and one capsule with snacks each day, continuously whilst on the study. This equates to approximately 9 capsules per day, depending on the number of meals taken. Reassessment of symptoms at one months may lead to a dose escalation up to 3 capsules with meals and/or two capsules with snacks, in the pres
Oral pancreatic enzyme replacement therapy using a drug called Creon at a dose of 25,000 international units per capsule. This medication will be taken at an initial dose of 2 capsules with meals, and one capsule with snacks each day, continuously whilst on the study. This equates to approximately 9 capsules per day, depending on the number of meals taken. Reassessment of symptoms at one months may lead to a dose escalation up to 3 capsules with meals and/or two capsules with snacks, in the presence of symptoms suggestive of pancreatic exocrine insufficiency, such as bloating, flatulence and diarrhoea. The dose escalation equates to approximately 12-15 capsules per day, depending on the number of meals taken. The medication will be continued for at least 2 months, and until the participant does not tolerate it, or elects to discontinue study assessments, or the participant dies.
Sponsors
Calvary Mater Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Healthy volunteers
No
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
Outcome results
None listed