Quality of Life in Patients With Inoperable Malignant Bowel Obstruction

What Was Tested

The trial (phase 2) is built around Lanreotide.

It had two arms (groups): Standard care and Lanreotide Autogel (experimental) and Standard care (no intervention).

Standard care according to site clinical practice.

The registry classes the interventions as drug.

Who Took Part

The registry lists 43 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Provision of written informed consent prior to any study related procedure. Diagnosis of an inoperable malignant bowel obstruction, confirmed by appropriate imaging report. In case of peritoneal carcinomatosis, diagnostic confirmation by CT or MRI scan. Confirmed as inoperable after medical advice. Patient with a nasogastric tube or presenting with 3 or more episodes of vomiting every day in the last consecutive 48 hours.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: has operable obstruction or any sub-obstruction; has bowel obstruction due to a non-malignant cause; (hypokaliaemia, drug side-effects, renal insufficiency, etc); has signs of bowel perforation.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Lanreotide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Lanreotide study did not mask who received what.

It started in 2015-01 with completion listed for 2018-01-16.

It ran at 13 sites in Italy (13).

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: Least Squares (LS) Mean Area Under Curve (AUC) of Edmonton Symptom Assessment System (ESAS) Total Scores Collected for the First 7 Days; Full Analysis Set (FAS) (time frame: Baseline (Day 1, before randomisation), Days 2, 3, 4, 5, 6 and 7).

It also tracked 9 secondary outcomes, for example Mean Change From Baseline in ESAS Total Score; FAS, Mean Change From Baseline in ESAS Total Score; ITT Population, Mean Change From Baseline in Single ESAS Items Symptom Scores; ITT Population, Mean Change From Baseline in Performing General Activity (Karnofsky Performance Status [KPS]); ITT Population, Mean Change From Baseline in Daily Intensity of Abdominal Pain Score (Visual Analogue Scale [VAS]); ITT Population and Number of Patients Experiencing ≤ 2 Vomiting Episodes/Day During at Least 3 Consecutive Days, in Patients Without NGT.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Lanreotide in 43 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Lanreotide compound page, all human trials.