Comparison of octreotide administration vs conservative treatment in the management of inoperable bowel obstruction in patients with far advanced cancer: a randomized, double- blind, controlled clinical trial.

Background: Conservative treatment of inoperable bowel obstruction in terminal cancer patients has been found to be effective in controlling the distressing symptoms caused by this complication. The purpose of this study was to evaluate the efficacy of octreotide in the management of nausea, vomiting and abdominal pain, secondary to bowel obstruction in terminally ill cancerpatients, when surgery was inappropriate.

Patients And Methods: Sixty-eight terminally ill cancer patients participated in the study (age range 42-77 years, 36 male, 32 female). The primary cancer location was in the gastrointestinal system, the abdomen and the pelvis. The survival time ranged from 7 to 61 days. Diagnosis was made on clinical grounds and confirmed by plain abdominal radiography. The patients were randomly assigned into two equal groups, A (N=34) and B (N=34). Group A received, by continuous subcutaneous (c.sc.) administration with a pump: hyoscine butylbromide 60-80mg/day and chlorpromazine (15-25 mg/day); group B received octreotide 600-800 microg/day and chlorpromazine (15-25 mg/day). As an opioid, patients received either a low-dose of morphine (1,530mg/day) in continuous subcutaneous administration or TTS Fentanyl (25-75 microg/hour). Diary cards were used to monitor vomiting. nausea, pain intensity, anorexia and fatigue. The symptoms were assessed at T1-baseline, T2 and T3-third and sixth day of treatment, respectively, and T4- one day before death.

Results: Data analysis showed there were statistically significant differences between the two groups: a) in vomiting and nausea in relation to percentage change from T1 to T2 and b) in fatigue and anorexia in relation to symptom improvement at T1 to T2, T1 to T3 and T1 to T4 (p<0.05), while in pain there was no statistically significant difference between the two groups in relation to percentage change from T1 to T2, T1 to T3 and T1 to T4.

Conclusion: The administration of octreotide, in combination with traditional pharmacological treatment, can be very effective in the symptom management of inoperable bowel obstruction in terminal cancerpatients