Octreotide Treatment to Improve Nutritional Recovery After Surgery for Patients with Esophageal or Gastric Cancer

What Was Tested

In this phase 2 trial, researchers set out to test Octreotide.

It had two arms (groups): Control (no intervention) and Octreotide (experimental).

Standard treatment.

The registry classes the interventions as drug.

More on the Plan

Dietary complications are the biggest problem for patients before, during and after surgical treatment.

The scientific state of knowledge about HRQOL and the symptoms of long-term survival of esophageal cancer is limited.

Patient-reported outcome measures (PRUs) are results reported by the patient himself, e.g.

HRQOL, remaining symptoms, satisfaction with health care and other problems in daily life.

Who Took Part

Enrollment: 20 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: Pathologic anatomic analysis (PAD) confirmed esophageal or gastric cancer. Gastrectomy or esophagectomy with curative intent. ≥18 years of age. Signed informed consent. Able to comply with the procedures of the study protocol, in the opinion of the investigator.

The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: non-radical operation (defined by macroscopic assessment) or metastatic disease diagnosed at the time of surgery; complications leading to restrictions in postoperative oral intake; advanced comorbidity with asa score iii or more.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.

The Octreotide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

It started in 2021-06-16 with completion listed for 2024-02-21.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Weight change in percent (%) (time frame: From baseline before surgery, at 1, 2, 3, and 6 months).

It also tracked 9 secondary outcomes, for example Changes in gastrointestinal satiety hormone levels, Changes in body composition, Changes in nutritional status - PG-SGA, Changes in nutritional status - EORTC CAX24, Health-related Quality of Life - EORTC QLQ-C30 and Health-related Quality of Life - QLQ-OG25.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Octreotide in 20 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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