Palliative Management of Inoperable Malignant Bowel Obstruction

What Was Tested

This registered phase 2 trial tested Octreotide.

To identify the role of palliative medical management of inoperable malignant bowel obstruction (MBO) with Octreotide, Dexamethasone and Metoclopramide given together as triple therapy.

It had 1 arm (groups): Treatment (octreotide, dexamethasone, metoclopramide) (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 15 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: Age ≥ 18 years of age. Diagnosis of partial bowel obstruction secondary to active or prior malignancy (primary or metastatic GI, GYN, and carcinomatosis) caused either by tumor itself or adhesions inthe setting of active malignancy. Cross-sectional imaging performed within 24 hours of clinical symptoms of bowel obstruction (nausea, vomiting, and constipation ± abdominal pain) during hospital admission. Patient must have an inoperable MBO. Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved writteninformed consent form prior to receiving any study related procedure.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: evidence of complete bowel obstruction by imaging; bacteremia/septicemia with a documented positive blood culture: if a blood culture comes back positive after study enrollment, patient will be excluded; patients undergoing bowel surgery or stent placement for bowel obstruction.

How the Study Was Run

It was run as a single-group and open-label study.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2019-06-26 with completion listed for 2021-09-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Proportion of Patients With Obstruction Clearance (time frame: Within 7 days of starting protocol therapy).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Octreotide in 15 people.

Its size is small, so on its own it can only give an early look.

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

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