A Study to Evaluate Patient Experience in the Therapy of Neuroendocrine Tumors Treated With Octreotide Long Acting Release Versus Lanreotide

What Was Tested

This registered phase 4 trial tested Octreotide and Lanreotide.

This study is being done to evaluate differences in patient experience during treatment with octreotide LAR and lanreotide.

It had two arms (groups): Octreotide then Lanreotide (experimental) and Lanreotide then Octreotide (experimental).

Each patient on study will receive three injections of intramuscular (IM) octreotide Long Acting Release (LAR). Octreotide LAR for 3 injections followed by lanreotide for 3 injections.

Each patient on study will receive three injections of deep subcutaneous (subq) lanreotide. Lanreotide for 3 injections followed by octreotide LAR for 3 injections.

The registry classes the interventions as behavioral and drug.

Who Took Part

Enrollment: 51 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: Willing and able to provide written informed consent for the trial. ≥ 18 years of age. Histologically- or cytologically- confirmed locally advanced or metastatic WDNET. SSA therapy is recommended by physician for disease management, and has not yet begun. ECOG performance status of 0, 1, or 2.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: currently participating in a study of an investigational agent; no concurrent chemotherapy or targeted small molecule therapy; if received major surgery, not recovered adequately from the toxicity and/or complications from the intervention prior to starting the study.

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 2017-09-19 with completion listed for 2023-04-10.

It ran at 7 sites in United States (7).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean Pain Scores at 3 Months (time frame: 3 months).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Octreotide and Lanreotide in 51 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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