None listed
Conditions
Brief summary
This study looks at the effectiveness of the drug octreotide in palliative care management of bowel obstruction caused by cancer in people with advanced cancer. Who is it for? You can join this study if you have widespread and advanced cancer and you have a related bowel obstruction which requires hospital admission or a change in care if you are already in hospital, but surgical removal is not currently considered appropriate. Trial details Participants will be randomly divided into two groups. One group will receive a continuous infusion of the drugs octreotide and ranitidine under the skin (subcutaneous) in addition to intravenous doses of dexamethasone and intravenous or subcutaneous fluids for 72 hours. The other group (control) will receive fluids under the skin only. Bowel obstruction is a common medical problem in people with advanced cancer. Current treatment options include combinations of surgery (where this is possible), nil by mouth, a feeding tube placed into the stomach, pain relief, and medications that reduce secretions. None of these options has been tested in a study that is large enough to determine which works best. Octreotide can inhibit the release of hormones that cause secretions into the gut that may make the pain of bowel obstruction worse. Inhibiting these secretions with Octreotide may help relieve pain and improve the quality of life.
Interventions
A phase III randomised, double blind, placebo controlled trial of octreotide (600mcg) delivered by continuous subcutaneous infusion used in conjunction with bolus daily parenteral (subcutaneous or intravenous) dexamethasone (8mg), ranitidine (200mg per 24 hours, either as bolus or continuous subcutaneous infusion) and parenteral hydration (continous subcutaneous or intravenous infusion) of(10mls/kg/24hours) over a maximum of 72 hours.
Sponsors
Flinders University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
age >18 years advanced cancer disease-modifying therapy (chemotherapy, radiotherapy, hormone therapy, biological/targeted therapies) is deemed by relevant practitioners unlikely to change the bowel obstruction or the course of cancer. presents with clinically confirmed bowel obstruction at any level and vomiting that precipitates a hospital admission or change in clinical care for those already in-patients deemed by two consultant level medical practitioners that this person has a bowel obstruction (partial or complete) for which immediate surgery is not indicated participant is capable of completing assessments and complying with the study procedures participant is able to give fully informed written consent Mini Mental State of >23 Not currently on octreotide
Exclusion criteria
previous adverse reaction to any of the study medications Australian-modified Karnofsky performance score less than 30 at the beginning of the study participants who have participated in a clinical study of a new chemical entity within the month prior to study entry. calculated creatinine clearance <10ml/min documented cirrhosis venting or feeding gastrostomy or jejunostomy
Outcome results
None listed