Conditions: Peritoneal Neoplasms Intestinal Obstruction Carcinomatosis
Keywords: bowel obstruction, peritoneal carcinomatosis Octreotide inoperable
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 64
Healthy volunteers: no

Brief summary:
To evaluate in combination with corticosteroid and local standard medical care the efficacy and safety of long-acting octreotide compared to placebo for the treatment of symptoms of inoperable bowel obstruction in patients with peritoneal carcinomatosis

Detailed description:

Arms:
arm 1: Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days. arm 2: Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.

Interventions: intervention 1: Octreotide LAR intervention 2: Octreotide (Immediate release) intervention 3: methylprednisolone intervention 4: Placebo
Intervention descriptions: intervention 1: Octreotide long-acting release (LAR) 30 mg intramuscular injection. intervention 2: Immediate-release Octreotide supplied in 100 µg/mL ampules. intervention 3: methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections). intervention 4: Physiologic saline solution

Protocol document: