Clinical Trial: Efficacy and Safety of Lanreotide 120 Milligram (mg) as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in Inoperable Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective Study to Assess the Efficacy and Safety of Lanreotide 120 mg as a Palliative Treatment of Clinical Symptoms Associated With Malignant Intestinal Obstruction in

Brief Summary:

The primary objective of this study is to assess the efficacy of Lanreotide 120 mg for the relief of clinical symptoms due to malignant bowel obstruction in inoperable patients. This effect will be evaluated by the percentage of responder patients 7 and 14 days after one administration of lanreotide 120 mg.

(A responder patient will be defined either as a patient experiencing < or= 1 vomiting episode per day during at least three consecutive days or as a patient in whom NGT has been removed without any vomiting recurrence during at least three consecutive days)

The total number of visits will depend on the clinical situation, 5 visits are obligatory: Day(D)-3/-0,Day 1,Day 7,Day 14,Day 28

Inclusion visit (D-3/-0): eligibility, PIC, obstruction history, clinical exam, vital signs, diary cards, VAS scale, cc medication, blood sample

Visit D1: injection Visit D7/D14/28: clinical exam, nutrition procedure, result of biochemical analyse, adverse events, cc medication

In between the visits, the patient will keep and fill out his diary and VAS scale


Detailed Summary:
Sponsor: University Hospital, Ghent

Current Primary Outcome: Percentage of responder patients. [ Time Frame: At day 7 and day 14. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of daily vomiting episodes on diary cards or measurements of the daily drainage by naso gastric tube (NGT). [ Time Frame: day 7, day 14 and day 28 after administration of Lanreotide ]
  • Number of days without vomiting episodes [ Time Frame: day 7, day 14 and day 28 after administration of Lanreotide ]
  • Number of daily nausea episodes recorded on diary cards. [ Time Frame: day 7, day 14 and day 28 after administration of Lanreotide ]
  • Intensity of abdominal pain assessed on a visual analogue scale. [ Time Frame: day 7, day 14 and day 28 after administration of Lanreotide. ]
  • Well-being assessed on a visual analogue scale. [ Time Frame: day 7, day 14 and day 28 after administration of Lanreotide. ]
  • Time between first injection and clinical response. [ Time Frame: day 7, day 14 and day 28 after administration of Lanreotide ]
  • Clinical and biological adverse events. [ Time Frame: day 7, day 14 and day 28 after administration of Lanreotide. ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Ghent

Dates:
Date Received: December 2, 2009
Date Started: October 2009
Date Completion:
Last Updated: December 4, 2014
Last Verified: December 2014