Extended-release of Octreotide (LF-PB) for the Treatment of Lymphorrhea

What Was Tested

The trial (phase 2) is built around Octreotide.

This is a phase II, multicenter, double-blind, double-dummy, parallel-group, placebo-controlled, study to evaluate LF-PB versus placebo in female patients with brest cancer who are undergoing breast surgery with axillary lymphnode dissection.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 114 actual participants took part.

It was open to women only aged from 18 years up to 80 years.

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

Examples of who could join: Female aged 18 to 80 years inclusive. Body mass index (BMI) ≥18 kg/m2. Signed informed consent form. Diagnosis of BC. Undergoing breast surgery with ALND Note: Collagen powder or fibrin sealant are not permitted.

The full record lists 8 inclusion and 18 exclusion criteria; among the exclusions: presence of any of the following conditions:; previous axillary surgery on the same armpit undergoing surgery in this study; previous chemotherapy or radiotherapy within five years from study drug administration.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

As a double-blind Octreotide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2012-11 with completion listed for 2014-05.

It ran at 13 sites in Italy (13).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: effect of LF-PB [amount hidden], and [amount hidden] on time to resolution of lymphorrhea;. number of AEs and laboratory, ECG, vital sign abnormalities of LF-PB [amount hidden], and [amount hidden].

It also tracked 3 secondary outcomes, for example number of complications related to lymphorrhea.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Octreotide in 114 people.

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.